drugset / Trial / NCT01739218

A Study of Bevacizumab (Avastin) in Neoadjuvant Therapy in Participants With International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC/IV Ovarian, Tubal, or Peritoneal Cancer, Initially Unresectable

NCT01739218 ↗

Phase 2 Completed 99 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-02-01
Primary completion
2016-08-17
Completion
2016-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous

Indications