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NCT01802749 · CITED IN SOURCE DOCUMENTS

Bevacizumab Beyond Progression in Platinum Sensitive Ovarian 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
UNKNOWN
Registry last update
2023-03-24

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

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.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Female patients ≥18 years of age. * Patients with histologically confirmed epithelial ovarian or fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours * Recurrence or progression at least 6 months after the last chemotherapy cycle of a first line carboplatin + paclitaxel chemotherapy including bevacizumab (recurrence or progression might occur either during or after bevacizumab as maintenance) * Patients can be included if they have a RECIST progression, with either measurable or non-measurable disease * ECOG (Eastern Cooperative Oncology Group Performance) Status of 0-2. * Life expectancy of at least 12 weeks. * Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements including blood samples for molecular analyses. * Availability of tumour samples for molecular analyses from primary surgery (mandatory) and secondary surgery (when available) Exclusion Criteria: Cancer related * Ovarian tumours with low malignant potential (i.e. borderline tumours) * History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met: * stage ≤Ia * no more than superficial myometrial invasion * no lymphovascular invasion * not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma). * Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. Prior current or planned treatment: * More than one previous chemotherapy line * Previous therapy with other anti-angiogenetic agents different from bevacizumab. * Any prior radiotherapy to the pelvis or abdomen. * Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose.Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes (except for line patency, in which case international normalized ratio \[INR\] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed. * Current or recent (within 30 days of first study dosing) treatment with any other investigational drug. Laboratory: * Inadequate bone marrow function: ANC (absolute neutrophil count): \<1500/mm3, or platelet count \<100,000/mm3 or Haemoglobin \<9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9 g/dl. * Inadequate coagulation parameters: * activated partial thromboplastin time (APTT) \>1.5 x upper limit of normal (ULN) or * INR (international normalized ratio) \>1.5 * Inadequate liver function, defined as: * serum (total) bilirubin \>1.5 x ULN for the institution * AST/SGOT or ALT/SGPT \> 2.5 x ULN. * Inadequate renal function, defined as: * serum creatinine \>2.0 mg/dl or \>177 micromol/l * urine dipstick for proteinuria \>2+. Patients with ≥ 1+ proteinuria at baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in their 24-hour urine collection. Prior or concomitant conditions or procedures: * History or evidence of brain metastases or spinal cord compression. * Pregnant or lactating females. * History or evidence of thrombotic or haemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within ≤6 months prior to the first study treatment). * Uncontrolled hypertension (sustained systolic \>150 mm Hg and/or diastolic \>100 mm Hg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including: * myocardial infarction or unstable angina within ≤6 months prior to the first study treatment * New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF) * serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia) * peripheral vascular disease ≥grade 3 (i.e. symptomatic and interfering with activities of daily living requiring repair or revision). * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, or with signs of impending bowel obstruction within 6 months prior to the first study treatment. * Non-healing wound, ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations. * Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Combination chemotherapy with ONE of the following regimens: * PLD-C: Pegylated liposomal doxorubicin 30 mg/m2 + Carboplatin AUC (area under curve) 5 on day 1 every 4 weeks; * GEM-C: Gemcitabine 1000 mg/m2 on day 1, 8 every 21 + Carboplatin AUC of 4 on day 1 every 21 days; * PAC-C: Paclitaxel 175 mg/m2 on day 1, every 21 + Carboplatin AUC of 5 on day 1 every 21 days.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Drug: pegylated liposomal doxorubicin
    4. Drug: Gemcitabine
    label
    chemotherapy
    type
    ACTIVE_COMPARATOR
  2. description
    Combination chemotherapy AND bevacizumab with ONE of the following regimens: * PLD-C: Pegylated liposomal doxorubicin 30 mg/m2 + Carboplatin AUC 5 on day 1 every 4 weeks and Bevacizumab 10 mg/kg i.v. on Day 1 every 2 weeks; * GEM-C: Gemcitabine 1000 mg/m2 on day 1, 8 every 21 + Carboplatin AUC of 4 on day 1 every 21 days AND Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks;L * PAC-C: Paclitaxel 175 mg/m2 on day 1, every 21 + Carboplatin AUC of 5 on day 1 every 21 days AND Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks. Patients whose disease has not progressed after the initial six cycles of combination treatment will continue bevacizumab, at 15 mg/kg every 3 weeks until disease progression,unacceptable toxicity or patient withdrawn.
    intervention Names
    1. Drug: Bevacizumab
    2. Drug: Paclitaxel
    3. Drug: Carboplatin
    4. Drug: pegylated liposomal doxorubicin
    5. Drug: Gemcitabine
    label
    Chemotherapy and bevacizumab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Chemotherapy and bevacizumab
    name
    Bevacizumab
    other Names
    1. Avastin
    type
    DRUG
  2. arm Group Labels
    1. Chemotherapy and bevacizumab
    2. chemotherapy
    name
    Paclitaxel
    type
    DRUG
  3. arm Group Labels
    1. Chemotherapy and bevacizumab
    2. chemotherapy
    name
    Carboplatin
    type
    DRUG
  4. arm Group Labels
    1. Chemotherapy and bevacizumab
    2. chemotherapy
    name
    pegylated liposomal doxorubicin
    other Names
    1. Caelyx
    type
    DRUG
  5. arm Group Labels
    1. Chemotherapy and bevacizumab
    2. chemotherapy
    name
    Gemcitabine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
406
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. measure
    predictive clinical factors for efficacy of bevacizumab
    time Frame
    12 months
  2. measure
    correlation of baseline plasma biomarker expression and clinical outcome
    time Frame
    12 months
primary Outcomes
  1. description
    assessed by local Investigator
    measure
    progression free survival
    time Frame
    12 months
secondary Outcomes
  1. measure
    overall survival
    time Frame
    12 months
  2. description
    according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    measure
    number of complete or partial responses
    time Frame
    6 months
  3. description
    according to Common Toxicity Criteria for Adverse Events v. 4.03
    measure
    worst grade toxicity per patient
    time Frame
    evaluated every 3 weeks up to 12 months
  4. measure
    number of patients taking oral antidiabetic therapy
    time Frame
    at baseline
  5. measure
    number of patients taking antithrombotic therapy
    time Frame
    at baseline
  6. description
    as measured by independent central review
    measure
    progression free survival
    time Frame
    12 months
Full study description
brief Summary
Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.
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
  2. citation
    Pignata S, Lorusso D, Joly F, Gallo C, Colombo N, Sessa C, Bamias A, Salutari V, Selle F, Frezzini S, De Giorgi U, Pautier P, Bologna A, Orditura M, Dubot C, Gadducci A, Mammoliti S, Ray-Coquard I, Zafarana E, Breda E, Favier L, Ardizzoia A, Cinieri S, Largillier R, Sambataro D, Guardiola E, Lauria R, Pisano C, Raspagliesi F, Scambia G, Daniele G, Perrone F; MITO16b/MANGO-OV2/ENGOT-ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):267-276. doi: 10.1016/S1470-2045(20)30637-9.
    pmid
    33539744
    type
    DERIVED
  3. citation
    Arend R, Westin SN, Coleman RL. Decision analysis for secondline maintenance treatment of platinum sensitive recurrent ovarian cancer: a review. Int J Gynecol Cancer. 2020 May;30(5):684-694. doi: 10.1136/ijgc-2019-001041. Epub 2020 Feb 19.
    pmid
    32079709
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        any bleeding (12% vs. 42%), and any hypertension (3% vs. 41%). </li></ul></div></li><li>In an open-label, randomized, phase III trial (<a href="/clinicaltrials/NCT01802749">MITO16b/MANGO-OV2/ENGOT-ov17</a> [NCT01802749]), investigators enrolled 406 patients at first recurrence or progression at least 6 months after receiving fi
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        n (3% vs. 41%). </li></ul></div></li><li>In an open-label, randomized, phase III trial (<a href="/clinicaltrials/NCT01802749">MITO16b/MANGO-OV2/ENGOT-ov17</a> [NCT01802749]), investigators enrolled 406 patients at first recurrence or progression at least 6 months after receiving first-line platinum-based treatment, including b
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      source title
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Not medical advice