Ovarian Cancer
Conditions
Brief summary
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.
Interventions
DRUGCarboplatin
Carboplatin will be administered at a dose calculated according to the Calvert formula (\[participant's glomerular filtration rate + 25\] multiplied by the target area under the concentration-time curve \[AUC\] of 5 milligrams per milliliter per minute \[mg/mL/min\]), as intravenous \[IV\] infusion over 30-60 minutes \[min\] every 3 weeks).
DRUGPaclitaxel
Paclitaxel will be administered at a dose of 175 milligrams per meter-squared \[mg/m\^2\] as IV infusion over 3 hours using a rate controlling device every 3 weeks, or at a dose of 80 mg/m\^2 as IV infusion over 1 hour using a rate controlling device every week (only during Cycles 5 to 8).
DRUGBevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram \[mg/kg\] as IV infusion over 30-90 min every 3 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Complete Resection After IDS | After IDS (approximately 4 months from randomization) |
| Percentage of Participants with Different CC Scores After IDS | After IDS (approximately 4 months from randomization) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with RECIST v1.1 Objective Response and CA-125 Response | At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months) |
| Percentage of Participants with RECIST v1.1 Objective Response Without CA-125 Response | At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months) |
| Percentage of Participants with CA-125 Response Without RECIST v1.1 Objective Response | At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months) |
| Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last tumor assessment (up to approximately 38 months) |
| Progression-Free Survival (PFS) According to RECIST v1.1 | From Baseline to disease progression or death due to any cause (up to approximately 38 months) |
| Percentage of Participants with Serious Adverse Events (SAEs) and Non-SAEs | SAEs: from randomization up to last assessment (up to approximately 38 months); non-SAEs: from Day 1 up to 28 days after last dose (up to approximately 23 months) |
| Number of Participants with Disease Progression or Death From any Cause | From Baseline to disease progression or death due to any cause (up to approximately 38 months) |
| Percentage of Participants with Response According to Cancer Antigen (CA)-125 Levels | At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last CA-125 assessment (up to approximately 38 months) |
Countries
France
Outcome results
None listed