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Sponsor: Hoffmann-La Roche
Conditions: Ovarian Cancer
Interventions: Carboplatin, Paclitaxel, Bevacizumab
Countries: France
This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery \[IDS\]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Histologically confirmed and documented high-risk FIGO stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma * Not eligible for primary complete debulking surgery during a laparoscopic procedure as judged by a surgeon experienced in management of ovarian cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Life expectancy greater than or equal to (\>/=) 3 months * Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards * Beneficiaries of healthcare coverage under the social security system Exclusion Criteria: * Non-epithelial ovarian cancer, ovarian tumor with low malignant potential, mucinous and clear cell ovarian cancer, or carcinosarcoma * Evidence of abdominal free air not explained by paracentesis or recent surgical procedure * Previous systemic therapy for ovarian cancer * Previous exposure to mouse CA-125 antibody * Current or recent (within 28 days prior to Day 1 of Cycle 1) treatment with another investigational drug or previous participation in this study * Current or recent (within 10 days prior to first study drug dose) chronic daily treatment with aspirin greater than (\>) 325 milligrams (mg) per day * Planned intraperitoneal cytotoxic chemotherapy * Inadequate bone marrow, liver, or renal function * History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to Day 1 of Cycle 1 * Uncontrolled hypertension * Clinically significant (active) cardiovascular disease such as New York Heart Association (NYHA) Class II or greater congestive heart failure, or aortic aneurism * Pre-existing peripheral neuropathy that is Common Toxicity Criteria (CTC) Grade \>/=2 * Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell products or other recombinant humanized antibodies, or to any planned chemotherapy * Pregnant or lactating females * History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- Amiens, France
- Besançon, France
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Lille, France
- Marseille, France
- Montpellier, France
- Nice, France
- Paris, France
- Paris, France
- Paris, France
- Saint-Cloud, France
- Toulouse, France
- Villejuif, France