Skip to content
← Study library

NCT00803062 · CITED IN SOURCE DOCUMENTS

Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2019-07-23

This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy * All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT; biopsy confirmation is required if the lesion(s) measures \< 30 mm or if the treating physician determines it is clinically indicated; patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be the one that was biopsied if one was performed; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Absolute neutrophil count (ANC) \>= 1500/mcl * Platelets \>= 100,000/mcl * Serum creatinine =\< upper limit of normal (ULN) (Common Toxicity Criteria \[CTC\] grade 0) or calculated creatinine clearance (Jeliffe formula) \>= 60 ml/min * Bilirubin =\< 1.5 x institutional normal * Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 x institutional normal * Alkaline phosphatase =\< 2.5 x institutional normal * Prothrombin time (PT) such that international normalized ratio (INR) is =\< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) * Partial thromboplastin time (PTT) \< 1.2 times the upper limit of normal * Urine protein-creatinine ratio (UPC ratio) \< 1.0 * Patients must have a GOG performance status of 0 or 1 * Patients must have recovered from the effects of surgery, radiation therapy, or chemoradiotherapy; at least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone; at least six weeks must have elapsed from the time of any major surgical procedure prior to randomization * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must meet all of the pre-entry requirements, including baseline QOL questionnaire * Patients must be free of active infection requiring antibiotics Exclusion Criteria: * Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage * Patients previously treated with chemotherapy except when used concurrently with radiation therapy * Patients who have received concurrent paclitaxel and/or concurrent topotecan with radiation therapy are ineligible * Patients with craniospinal metastases * Patients with a concomitant malignancy other than non-melanoma skin cancer * Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy * Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess for which an interval of 3 to 6 months must pass before study entry; in addition, the patient must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations * Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels * Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study * Patients with clinically significant cardiovascular disease; this includes: * Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg * Myocardial infarction or unstable angina \< 6 months prior to registration * New York Heart Association (NYHA) grade II or greater congestive heart failure * Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate * CTCAE grade 2 or greater peripheral vascular disease (at least brief \[\< 24 hours (hrs)\]) episodes of ischemia managed non-surgically and without permanent deficit) * History of CVA within six months * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Patients with or with anticipation of invasive procedures as defined below: * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy * Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures * Core biopsy, within 7 days prior to randomization * Patients who are pregnant or nursing; bevacizumab should not be administered to pregnant women; bevacizumab should not be administered to nursing women; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy * Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab * Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition * Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard * Patients with significant peripheral vascular disease * Patients with pre-existing grade 2 or greater peripheral neuropathy
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2.
    intervention Names
    1. Drug: Cisplatin
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Paclitaxel
    4. Other: Quality-of-Life Assessment
    5. Other: Questionnaire Administration
    label
    Arm I (paclitaxel and cisplatin)
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2.
    intervention Names
    1. Biological: Bevacizumab
    2. Drug: Cisplatin
    3. Other: Laboratory Biomarker Analysis
    4. Drug: Paclitaxel
    5. Other: Quality-of-Life Assessment
    6. Other: Questionnaire Administration
    label
    Arm II (paclitaxel, cisplatin, bevacizumab)
    type
    EXPERIMENTAL
  3. description
    Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
    intervention Names
    1. Other: Laboratory Biomarker Analysis
    2. Drug: Paclitaxel
    3. Other: Quality-of-Life Assessment
    4. Other: Questionnaire Administration
    5. Drug: Topotecan Hydrochloride
    label
    Arm III (topotecan hydrochloride and paclitaxel)
    type
    EXPERIMENTAL
  4. description
    Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
    intervention Names
    1. Biological: Bevacizumab
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Paclitaxel
    4. Other: Quality-of-Life Assessment
    5. Other: Questionnaire Administration
    6. Drug: Topotecan Hydrochloride
    label
    Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (paclitaxel, cisplatin, bevacizumab)
    2. Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
    description
    Given IV
    name
    Bevacizumab
    other Names
    1. Anti-VEGF
    2. Anti-VEGF Humanized Monoclonal Antibody
    3. Anti-VEGF rhuMAb
    4. Avastin
    5. Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
    6. Recombinant Humanized Anti-VEGF Monoclonal Antibody
    7. rhuMab-VEGF
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm I (paclitaxel and cisplatin)
    2. Arm II (paclitaxel, cisplatin, bevacizumab)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  3. arm Group Labels
    1. Arm I (paclitaxel and cisplatin)
    2. Arm II (paclitaxel, cisplatin, bevacizumab)
    3. Arm III (topotecan hydrochloride and paclitaxel)
    4. Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  4. arm Group Labels
    1. Arm I (paclitaxel and cisplatin)
    2. Arm II (paclitaxel, cisplatin, bevacizumab)
    3. Arm III (topotecan hydrochloride and paclitaxel)
    4. Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
    description
    Given IV
    name
    Paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. Bristaxol
    4. Praxel
    5. Taxol
    6. Taxol Konzentrat
    type
    DRUG
  5. arm Group Labels
    1. Arm I (paclitaxel and cisplatin)
    2. Arm II (paclitaxel, cisplatin, bevacizumab)
    3. Arm III (topotecan hydrochloride and paclitaxel)
    4. Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  6. arm Group Labels
    1. Arm I (paclitaxel and cisplatin)
    2. Arm II (paclitaxel, cisplatin, bevacizumab)
    3. Arm III (topotecan hydrochloride and paclitaxel)
    4. Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
    description
    Ancillary studies
    name
    Questionnaire Administration
    type
    OTHER
  7. arm Group Labels
    1. Arm III (topotecan hydrochloride and paclitaxel)
    2. Arm IV (topotecan hydrochloride, paclitaxel, bevacizumab)
    description
    Given IV
    name
    Topotecan Hydrochloride
    other Names
    1. Hycamptamine
    2. Hycamtin
    3. SKF S-104864-A
    4. Topotecan HCl
    5. topotecan hydrochloride (oral)
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
452
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.
    measure
    Extent of Nicotine Dependence
    time Frame
    Up to 5 years
  2. description
    Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.
    measure
    Health-related Quality of Life
    time Frame
    Up to 9 months after course 1
  3. description
    Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
    measure
    Levels of Angiogenesis Markers in Plasma
    time Frame
    Up to 5 years
  4. description
    Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
    measure
    Levels of Cell-free DNA in Plasma
    time Frame
    Up to 5 years
  5. description
    Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
    measure
    Levels of Tumor Measures of Angiogenesis
    time Frame
    Up to 5 years
  6. description
    Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.
    measure
    Number of CTCs
    time Frame
    Up to 5 years
  7. description
    An estimate of the prevalence of active smoking will be calculated. Will be assessed for associations with progression and/or death.
    measure
    Prevalence of Active Smoking
    time Frame
    Up to 5 years
primary Outcomes
  1. description
    The observed length of life from randomization into the study to death or the date of last contact.
    measure
    Overall Survival
    time Frame
    From entry into the study to death or the date of last contact, assessed up to 5 years
  2. description
    Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
    measure
    Progression-free Survival
    time Frame
    From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)
  3. description
    Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.
    measure
    Tumor Response
    time Frame
    Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.
  4. description
    The number of patients on each arm who have Grade 3 AE or higher toxicity.
    measure
    To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
    time Frame
    From date of enrollment until 30 days after treatment completion
Full study description
brief Summary
This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.
detailed Description
PRIMARY OBJECTIVES: I. To determine whether the addition of bevacizumab to chemotherapy improves overall survival. Also to determine if a regimen involving paclitaxel and topotecan improves overall survival in comparison to a regimen involving cisplatin and paclitaxel. These regimens are to be evaluated in patients with stage IVB, recurrent, or persistent carcinoma of the cervix. II. To determine and compare the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 for the regimens administered on this study. SECONDARY OBJECTIVES: I. To estimate and compare the progression-free survival of patients treated by the regimens investigated on this study. II. To estimate and compare the proportion of patients with tumor responses by the regimens investigated on this study. TERTIARY OBJECTIVES: I. To determine whether the addition of bevacizumab to chemotherapy, or the substitution of cisplatin with topotecan improve the health related quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index scale (FACT-Cx TOI) and produce favorable toxicity profiles (with a particular focus on peripheral neuropathy as measured by the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity version 4 \[FACT/GOG-Ntx4\] subscale and pain as measured by Brief Pain Inventory \[BPI\] single item). II. To evaluate the impact of age, race, performance status, stage, histology, grade, disease site, prior chemotherapy with primary radiation, and time to recurrence on response rate, progression-free survival and overall survival of patients with metastatic/recurrent/persistent carcinoma of the cervix. III. To determine the prevalence of active smoking in this cohort of recurrent cervical cancer patients. IV. To estimate the extent of tobacco/nicotine dependence in the cohort. V. To determine if smoking is an independent risk factor for progression-free survival and overall survival in this population. VI. To isolate, enumerate and characterize circulating tumor cells (CTC) recovered from blood drawn pre-cycle 1, pre-cycle 2 and pre-cycle 3 using the CTC-chip developed by the Massachusetts General Hospital (MGH) BioMEMS Resource Center and the MGH Cancer Center. VII. To determine the association between CTC counts or characteristics and measures of clinical outcome. VIII. To examine the association between angiogenesis markers in plasma (recovered from blood drawn pre-cycle 1, pre-cycle 2 and pre-cycle 3) and measures of clinical outcome. IX. To evaluate the association between tumor markers of angiogenesis and hypoxia (using archival formalin-fixed and paraffin-embedded tumor tissue) and measures of clinical outcome. X. To evaluate the association between single nucleotide polymorphisms (using deoxyribonucleic acid \[DNA\] extracted from whole blood) and measures of clinical outcome as well as measures of quality of life such as chemotherapy toxicity. XI. To examine the relationship(s) among the various biomarkers. XII. To develop an optimal prognostic model for progression-free survival and overall survival using clinical covariates, smoking status and the various biomarkers. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2. ARM II: Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2. ARM III: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3. ARM IV: Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3. In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Source references
references
  1. citation
    Tewari KS, Sill MW, Birrer MJ, Penson RT, Huang H, Moore DH, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomized study. Gynecol Oncol. 2023 Apr;171:141-150. doi: 10.1016/j.ygyno.2023.01.010. Epub 2023 Mar 8.
    pmid
    36898292
    type
    DERIVED
  2. citation
    Tewari KS, Sill MW, Monk BJ, Penson RT, Moore DH, Lankes HA, Ramondetta LM, Landrum LM, Randall LM, Oaknin A, Leitao MM, Eisenhauer EL, DiSilvestro P, Van Le L, Pearl ML, Burke JJ, Salani R, Richardson DL, Michael HE, Kindelberger DW, Birrer MJ. Circulating Tumor Cells In Advanced Cervical Cancer: NRG Oncology-Gynecologic Oncology Group Study 240 (NCT 00803062). Mol Cancer Ther. 2020 Nov;19(11):2363-2370. doi: 10.1158/1535-7163.MCT-20-0276. Epub 2020 Aug 26.
    pmid
    32847980
    type
    DERIVED
  3. citation
    Tewari KS, Sill MW, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, DiSaia PJ, Copeland LJ, Creasman WT, Stehman FB, Brady MF, Burger RA, Thigpen JT, Birrer MJ, Waggoner SE, Moore DH, Look KY, Koh WJ, Monk BJ. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017 Oct 7;390(10103):1654-1663. doi: 10.1016/S0140-6736(17)31607-0. Epub 2017 Jul 27.
    pmid
    28756902
    type
    DERIVED
  4. citation
    Penson RT, Huang HQ, Wenzel LB, Monk BJ, Stockman S, Long HJ 3rd, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Method M, Michael H, Tewari KS. Bevacizumab for advanced cervical cancer: patient-reported outcomes of a randomised, phase 3 trial (NRG Oncology-Gynecologic Oncology Group protocol 240). Lancet Oncol. 2015 Mar;16(3):301-11. doi: 10.1016/S1470-2045(15)70004-5. Epub 2015 Jan 29.
    pmid
    25638326
    type
    DERIVED
  5. citation
    Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa1309748.
    pmid
    24552320
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-199348c0ae40f0894f33
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      source record id
      25c471d4-a4c1-4f99-8848-c49ce5b0000a
      source file sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      payload sha256
      1684bb7770bb1bc557a6ea0478abf313fc5a284189b54195e05c52ecd7819da5
      payload
      application numbers
      1. BLA761231
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-199348c0ae40f0894f33
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        urrent, or metastatic cervical cancer in a randomized, four-arm, multicenter study comparing bevacizumab with chemotherapy versus chemotherapy alone [GOG-0240 (NCT00803062)]. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without bevacizumab, or paclitaxel and topotecan with or witho
        end
        16979
        exact text
        NCT00803062
        start
        16968
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00100.json
      source file sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      source json pointer
      /results/32/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      25c471d4-a4c1-4f99-8848-c49ce5b0000a
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      5661fdb9074fbb034143e12e4a4605083cbd33b4e3098809cb7343109493185d
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      spl effective time
      20260127
      spl set id
      42b4f96e-1f70-2126-e063-6294a90a93e3
    2. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-3a24b87ce22bfb460014
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=600&sort=id%3Aasc
      source record id
      ca8057b2-9aec-43bc-8525-cf8091433c71
      source file sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      payload sha256
      5f891528e765a7c181c05a510b5ae0f47c18138ccd9b757fb2c32f596f59bf2f
      payload
      application numbers
      1. BLA761231
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-3a24b87ce22bfb460014
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        urrent, or metastatic cervical cancer in a randomized, four-arm, multicenter study comparing bevacizumab with chemotherapy versus chemotherapy alone [GOG-0240 (NCT00803062)]. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without bevacizumab, or paclitaxel and topotecan with or witho
        end
        16979
        exact text
        NCT00803062
        start
        16968
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00600.json
      source file sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      source json pointer
      /results/67/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      ca8057b2-9aec-43bc-8525-cf8091433c71
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      5661fdb9074fbb034143e12e4a4605083cbd33b4e3098809cb7343109493185d
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=600&sort=id%3Aasc
      spl effective time
      20260323
      spl set id
      6b4040a2-a5c5-4ff0-ab45-935d7e49cf78
    3. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-633ff3b977a171f0102c
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
      source record id
      8debebf6-af94-4ba7-8d67-c801f4ea27eb
      source file sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      payload sha256
      a28824deb37c8b671bbc52e87d69f091a8532fca0ae005c7438b1fc05de0d440
      payload
      application numbers
      1. BLA125085
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-633ff3b977a171f0102c
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        recurrent, or metastatic cervical cancer in a randomized, four-arm, multicenter study comparing Avastin with chemotherapy versus chemotherapy alone [GOG-0240 (NCT00803062)]. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without Avastin, or paclitaxel and topotecan with or without A
        end
        16708
        exact text
        NCT00803062
        start
        16697
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00500.json
      source file sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      source json pointer
      /results/24/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      8debebf6-af94-4ba7-8d67-c801f4ea27eb
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6f9f86027b6f32969be7f30286f48e96e380fd91a3cb2490b51001f709a7db71
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
      spl effective time
      20250106
      spl set id
      939b5d1f-9fb2-4499-80ef-0607aa6b114e
    4. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-8b1428327a065016ec41
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      6955ea6d88f2638dea0c76acc97151b275d6a4c31db28ecdc8d9cabd729d6101
      payload sha256
      e4081e1271880e236484cff0b540354fc3fd13c5b4845be2cb563421c21d4f39
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-8b1428327a065016ec41
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        CDR0000810033&amp;version=HealthProfessional&amp;language=English'); return(false);">Level of evidence B4</a>]</li></ul></div></li><li><a href="/clinicaltrials/NCT00803062">GOG-0240</a> (NCT00803062), which enrolled patients with metastatic, persistent, or recurrent cervical carcinoma, was designed to answer the following two que
        end
        221959
        exact text
        NCT00803062
        start
        221948
      2. context exact
        ealthProfessional&amp;language=English'); return(false);">Level of evidence B4</a>]</li></ul></div></li><li><a href="/clinicaltrials/NCT00803062">GOG-0240</a> (NCT00803062), which enrolled patients with metastatic, persistent, or recurrent cervical carcinoma, was designed to answer the following two questions:[<a href="#cit/secti
        end
        221986
        exact text
        NCT00803062
        start
        221975
      3. context exact
        ination with other drugs):</p> <div class="pdq-content-list"><ol id="_663"><li>GOG-110, <a href="/clinicaltrials/NCT00003945">GOG-0179</a>, GOG-0169 (NCT00803062)<div class="pdq-content-list"><ul id="_664"><li>GOG-110: The ifosfamide + cisplatin combination was superior to cisplatin alone in the secondary end point of r
        end
        229663
        exact text
        NCT00803062
        start
        229652
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/54c89187d215055b46.html
      source file sha256
      6955ea6d88f2638dea0c76acc97151b275d6a4c31db28ecdc8d9cabd729d6101
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:36.858766+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      a3232984df74a1d9a0f043dc5a178abeec22b6bc2629401b770fc7d9a7b60dfd
      source title
      Cervical Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 13, 2025
        datetime
        2025-05-13T12:00:00Z
        display
        May 13, 2025
    5. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-a56e9a43c04883cb7b00
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=300&sort=id%3Aasc
      source record id
      598b7687-6daa-2ce7-e063-6394a90ab429
      source file sha256
      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
      payload sha256
      5c808476015871951ccddd7ce8b3d29b816a07d9a9448e96f07357539b4ab992
      payload
      application numbers
      1. BLA761268
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-a56e9a43c04883cb7b00
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        rrent, or metastatic cervical cancer in a randomized, four-arm, multicenter study comparing bevacizumab with chemotherapy versus chemotherapy alone [GOG-0240 ( NCT00803062 )]. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without bevacizumab, or paclitaxel and topotecan with or with
        end
        16982
        exact text
        NCT00803062
        start
        16971
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00300.json
      source file sha256
      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
      source json pointer
      /results/78/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      598b7687-6daa-2ce7-e063-6394a90ab429
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      20f4d916b986722fb555e4c9410051bc1746100f6c73529af41036961c7d881c
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=300&sort=id%3Aasc
      spl effective time
      20260821
      spl set id
      4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe
    6. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-a71ff769f64f15d7b02f
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      source record id
      2644fd0e-5b94-9120-bdb1-e275d982b249
      source file sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      payload sha256
      4fb744f8b0c3581a2194e51a117412522232ab0c0a88460e4bf06fb330c648ae
      payload
      application numbers
      1. BLA761175
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-a71ff769f64f15d7b02f
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        urrent, or metastatic cervical cancer in a randomized, four-arm, multicenter study comparing bevacizumab with chemotherapy versus chemotherapy alone [GOG-0240 (NCT00803062)]. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without bevacizumab, or paclitaxel and topotecan with or witho
        end
        17399
        exact text
        NCT00803062
        start
        17388
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00100.json
      source file sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      source json pointer
      /results/34/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      2644fd0e-5b94-9120-bdb1-e275d982b249
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e21069a0948bbce06a85786ddbbc2839d4f9236f5865abba3e3379c45bd1d271
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      spl effective time
      20260311
      spl set id
      70ab1de6-fb68-aee4-a6cb-f9a0f146687f
    7. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-bdfab3a1b45de8bcbb9d
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
      source record id
      ea079b8e-24b7-4e03-8340-8078f30f6d98
      source file sha256
      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
      payload sha256
      15e10f6a9d615cc3e33c48cd24813d021d4d6157503469ed904a7ae6677e4519
      payload
      application numbers
      1. BLA761028
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-bdfab3a1b45de8bcbb9d
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        urrent, or metastatic cervical cancer in a randomized, four-arm, multicenter study comparing bevacizumab with chemotherapy versus chemotherapy alone [GOG-0240 (NCT00803062)]. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without bevacizumab, or paclitaxel and topotecan with or witho
        end
        17000
        exact text
        NCT00803062
        start
        16989
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00700.json
      source file sha256
      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
      source json pointer
      /results/79/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      ea079b8e-24b7-4e03-8340-8078f30f6d98
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      bbf2f2af7cb8babda09095a78b354d15a500aba442759b04c1595566b0870385
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
      spl effective time
      20260623
      spl set id
      0a562b4e-67ce-4bab-852c-d9ee71e55fb8
    8. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-c1719f785efb42787f79
      requested nct id
      NCT00803062
      primary nct id
      NCT00803062
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
      source record id
      8f385b9e-2699-46a0-8c5f-ec1d86cd609d
      source file sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      payload sha256
      504270acd52ac3518c4af8719634b6027be0fb472da668e18fec6168c4d41cbc
      payload
      application numbers
      1. BLA761099
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-c1719f785efb42787f79
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00803062
      occurrences
      1. context exact
        urrent, or metastatic cervical cancer in a randomized, four-arm, multicenter study comparing bevacizumab with chemotherapy versus chemotherapy alone [GOG-0240 (NCT00803062)]. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without bevacizumab, or paclitaxel and topotecan with or witho
        end
        16956
        exact text
        NCT00803062
        start
        16945
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00500.json
      source file sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      source json pointer
      /results/27/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      8f385b9e-2699-46a0-8c5f-ec1d86cd609d
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      774cfec5b812453dac521297deff828caeb90e4c09011e2ec66273f66c607f0b
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
      spl effective time
      20260721
      spl set id
      aa27acbd-d117-4350-aeee-17bc2e2c0ca4

    Preserved source evidence · Not medical advice