NCT00434642

A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma

A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin was provided as commercially available drug.
DRUG	Gemcitabine	Gemcitabine was provided as commercially available drug.
DRUG	Bevacizumab	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.
DRUG	Placebo	Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-09-01
• Completion: 2013-07-01
• First posted: 2007-02-13
• Last updated: 2017-08-09
• Results posted: 2011-11-03