drugset / Trial / NCT00937560

A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

NCT00937560 ↗

Phase 2 Completed 190 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.

Timeline

Start
2009-06-25
Primary completion
2012-07-31
Completion
2013-07-01

Outcome

Met primary endpoint

paper CONCLUSION: OCTAVIA met its primary objective, demonstrating median PFS of approximately 2 years. PMID 24007819 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications