Conditions: Ovarian Cancer
Keywords: Avastin Ovarian carcinoma Peritoneal carcinoma Peritoneal cancer Fallopian tube cancer Fallopian tube carcinoma OCEANS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 484
Healthy volunteers: no

Brief summary:
This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

Detailed description:

Arms:
arm 1: Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study. arm 2: Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.

Interventions: intervention 1: Carboplatin intervention 2: Gemcitabine intervention 3: Bevacizumab intervention 4: Placebo
Intervention descriptions: intervention 1: Carboplatin was provided as commercially available drug. intervention 2: Gemcitabine was provided as commercially available drug. intervention 3: Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL \[25 mg/mL\]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP. intervention 4: Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Protocol document: