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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
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).
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).
Bevacizumab will be administered at a dose of 15 milligrams per kilogram \[mg/kg\] as IV infusion over 30-90 min every 3 weeks.
Chu D'Amiens
Amiens, France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, France
Institut Bergonie; Oncologie
Bordeaux, France
Centre Francois Baclesse; Chir Gynecologique
Caen, France
Centre Jean Perrin; Chir Generale Oncologie
Clermont-Ferrand, France
Centre Oscar Lambret; Cancerologie Gynecologique
Lille, France
Institut J Paoli I Calmettes; Chir II
Marseille, France
Centre Val Aurelle Paul Lamarque; Chir A1
Montpellier, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, France
Institut Curie; Chir Generale Gyneco Oncologique
Paris, France
...and 5 more locations
Percentage of Participants with Complete Resection After IDS
Time frame: After IDS (approximately 4 months from randomization)
Percentage of Participants with Different CC Scores After IDS
Time frame: After IDS (approximately 4 months from randomization)
Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last tumor assessment (up to approximately 38 months)
Percentage of Participants with Response According to Cancer Antigen (CA)-125 Levels
Time frame: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last CA-125 assessment (up to approximately 38 months)
Percentage of Participants with RECIST v1.1 Objective Response and CA-125 Response
Time frame: 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
Time frame: 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
Time frame: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
Number of Participants with Disease Progression or Death From any Cause
Time frame: From Baseline to disease progression or death due to any cause (up to approximately 38 months)
Progression-Free Survival (PFS) According to RECIST v1.1
Time frame: 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
Time frame: 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)
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