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NCT01081262 · REGISTRY CONDITION SEARCH

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-08-28

This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube 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.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival

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outcome · POSTED

Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Objective Tumor Response

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outcome · POSTED

Patient Reported Neurotoxicity

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outcome · POSTED

Patient Reported Quality of Life

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outcome · NOT POSTED

Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with a histologic diagnosis of mucinous adenocarcinoma of the ovary or fallopian tube with either optimal (=\< 1 cm residual disease) or suboptimal residual disease following initial surgery; patients may have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or no measurable disease * All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage * Patients must have stage II-IV disease (new or recurrent-chemonaïve; no brain metastasis) or recurrent stage I disease (chemonaïve) * Newly diagnosed patients must begin protocol therapy within 10 weeks of primary debulking; for stage I recurrent patients (chemonaïve), they should begin protocol therapy within 14 days of randomization * Patients must have a negative colonoscopy within 1 year of enrolling in the study * Absolute neutrophil count (ANC) \>= 1,500/mcl * White blood cell (WBC) count \>= 3,000/mcl * Platelets \>= 100,000/mcl * Hemoglobin (Hgb) \>= 10 g/dl (can be post transfusion) * Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance \> 50 cc/min * Bilirubin =\< 1.5 x ULN * Serum glutamic oxaloacetic transaminase (SGOT) =\< to 2.5 x ULN * Alkaline phosphatase =\< to 2.5 x ULN * Neuropathy (sensory and motor) =\< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 * Urine dipstick for proteinuria \< 2+; if urine dipstick is \>= 2+, 24 hour urine must demonstrate =\< 1 g protein in 24 hours OR patients must have a urine protein-to-creatinine ratio (UPCR) \< 1.0 mg/dL * Prothrombin time (PT) =\< 1.5 x ULN * Activated prothrombin time (APTT) =\< 1.5 x ULN * Patients of childbearing potential must agree to practice an effective form of birth control during study treatment and for six months after completion of treatment * Patients who have met the pre-entry requirements * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients with Gynecologic Oncology Group (GOG) performance grade of 0, 1 or 2 * Patients with life expectancy \> 3 months Exclusion Criteria: * Patients with known colon cancer or history of colon cancer * Patients with primary peritoneal carcinoma * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients who have received chemotherapy, radiotherapy or any investigational treatment for a gynecologic cancer (does include breast cancer) or colorectal cancer prior to enrollment * Patients with a major surgical procedure anticipated during the course of the study; this includes but is not limited to: abdominal surgery (laparotomy or laparoscopy) 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 * Patients may have minor surgical procedures (i.e., mediport insertion) fine needle aspiration or core biopsies as long as it is performed \> 7 days prior to the first date of bevacizumab therapy and there is no evidence of wound disruption or impaired healing * Patients with surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for fact that bevacizumab can be omitted from first cycle of chemotherapy) * Patients with a history of abdominal fistula or perforation within the past 12 months * Patients with a current, serious, non-healing wound, ulcer, or bone fracture; 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 known hypersensitivity to Chinese hamster cell products or other recombinant human or humanized antibodies * Patients with mixed epithelial ovarian cancer histology * Patients with tumors of low malignant potential * History or evidence of upon physical examination of central nervous system (CNS) disease, including history of primary brain tumor or any history of brain metastases, or seizures not controlled with standard medical therapy * Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 100 mm Hg; patients with a history of hypertension are permitted * Myocardial infarction or unstable angina within 12 months of the first date of bevacizumab therapy * New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction \< 50% will be excluded from the study * Grade 1, category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise * History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab therapy * History of pulmonary embolism or deep vein thrombosis in the past 6 months * Previous history of malabsorption or other conditions preventing oral treatment * Patients who are pregnant or nursing * Patients with acute hepatitis or active infection that requires parenteral antibiotics * Patients with active bleeding or pathologic conditions that carry a high risk of bleeding such as a known bleeding disorder, coagulopathy or tumor involving the major vessels * Patients taking warfarin
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 carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Carboplatin
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Paclitaxel
    4. Other: Quality-of-Life Assessment
    label
    Arm I (carboplatin and paclitaxel)
    type
    EXPERIMENTAL
  2. description
    Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Capecitabine
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Oxaliplatin
    4. Other: Quality-of-Life Assessment
    label
    Arm II (oxaliplatin and capecitabine)
    type
    EXPERIMENTAL
  3. description
    Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Biological: Bevacizumab
    2. Drug: Carboplatin
    3. Other: Laboratory Biomarker Analysis
    4. Drug: Paclitaxel
    5. Other: Quality-of-Life Assessment
    label
    Arm III (carboplatin, paclitaxel, bevacizumab)
    type
    EXPERIMENTAL
  4. description
    Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
    intervention Names
    1. Biological: Bevacizumab
    2. Drug: Capecitabine
    3. Other: Laboratory Biomarker Analysis
    4. Drug: Oxaliplatin
    5. Other: Quality-of-Life Assessment
    label
    Arm IV (oxaliplatin, capecitabine, bevacizumab)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm III (carboplatin, paclitaxel, bevacizumab)
    2. Arm IV (oxaliplatin, capecitabine, bevacizumab)
    description
    Given IV
    name
    Bevacizumab
    other Names
    1. ABP 215
    2. ABP-215
    3. ABP215
    4. Alymsys
    5. Anti-VEGF
    6. Anti-VEGF Humanized Monoclonal Antibody
    7. Anti-VEGF Monoclonal Antibody SIBP04
    8. Anti-VEGF rhuMAb
    9. Avastin
    10. Avegra
    11. Avzivi
    12. Aybintio
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm II (oxaliplatin and capecitabine)
    2. Arm IV (oxaliplatin, capecitabine, bevacizumab)
    description
    Given PO
    name
    Capecitabine
    other Names
    1. Ro 09-1978/000
    2. Xeloda
    type
    DRUG
  3. arm Group Labels
    1. Arm I (carboplatin and paclitaxel)
    2. Arm III (carboplatin, paclitaxel, bevacizumab)
    description
    Given IV
    name
    Carboplatin
    other Names
    1. Blastocarb
    2. Carboplat
    3. Carboplatin Hexal
    4. Carboplatino
    5. Carboplatinum
    6. Carbosin
    7. Carbosol
    8. Carbotec
    9. CBDCA
    10. Displata
    11. Ercar
    12. JM-8
    type
    DRUG
  4. arm Group Labels
    1. Arm I (carboplatin and paclitaxel)
    2. Arm II (oxaliplatin and capecitabine)
    3. Arm III (carboplatin, paclitaxel, bevacizumab)
    4. Arm IV (oxaliplatin, capecitabine, bevacizumab)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  5. arm Group Labels
    1. Arm II (oxaliplatin and capecitabine)
    2. Arm IV (oxaliplatin, capecitabine, bevacizumab)
    description
    Given IV
    name
    Oxaliplatin
    other Names
    1. 1-OHP
    2. Ai Heng
    3. Aiheng
    4. Dacotin
    5. Dacplat
    6. Diaminocyclohexane Oxalatoplatinum
    7. Eloxatin
    8. Eloxatine
    9. Elplat
    10. JM 83
    11. JM-83
    12. JM83
    type
    DRUG
  6. arm Group Labels
    1. Arm I (carboplatin and paclitaxel)
    2. Arm III (carboplatin, paclitaxel, bevacizumab)
    description
    Given IV
    name
    Paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. Bristaxol
    4. Praxel
    5. Taxol
    6. Taxol Konzentrat
    type
    DRUG
  7. arm Group Labels
    1. Arm I (carboplatin and paclitaxel)
    2. Arm II (oxaliplatin and capecitabine)
    3. Arm III (carboplatin, paclitaxel, bevacizumab)
    4. Arm IV (oxaliplatin, capecitabine, bevacizumab)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
50
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Will be tabulated. Interactions between the mutational status of the KRAS oncogene and treatment will be examined.
    measure
    Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene
    time Frame
    Baseline
primary Outcomes
  1. description
    Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
    measure
    Overall Survival
    time Frame
    Up to five years
secondary Outcomes
  1. description
    Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.
    measure
    Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
    time Frame
    Every cycle while on treatment, up to 5 years
  2. description
    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, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    measure
    Progression-free Survival
    time Frame
    Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
  3. description
    Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) 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; Overall response (OR) = CR + PR
    measure
    Objective Tumor Response
    time Frame
    CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years
  4. description
    Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
    measure
    Patient Reported Neurotoxicity
    time Frame
    baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
  5. description
    Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL
    measure
    Patient Reported Quality of Life
    time Frame
    baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Full study description
brief Summary
This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.
detailed Description
PRIMARY OBJECTIVES: I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube. II. To determine if bevacizumab reduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube. SECONDARY OBJECTIVES: I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube. II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube. III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery. IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery. V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients. VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients. VII. To compare capecitabine and oxaliplatin versus carboplatin and paclitaxel with respect to changes in patient reported neurotoxicity. VIII. To determine the impact on quality of life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian \[FACT-O\] Trial Outcome Index \[TOI\]) following treatment with the above regimens. TERTIARY OBJECTIVES: I. To collect fixed and/or frozen tissue and whole blood for future research studies. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive carboplatin intravenously (IV) over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
Source references
references
  1. citation
    Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
    pmid
    37185961
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice