CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 190 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00937560
NCT00937560Phase 2Completed

A Single-arm Phase II Clinical Study Investigating the Addition of Bevacizumab to Carboplatin and Weekly Paclitaxel as First-line Treatment in Patients With Epithelial Ovarian Cancer

Hoffmann-La Roche·interventional·Posted Jul 13, 2009·Updated Nov 6, 2017

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Paclitaxel, and 1 other intervention for Ovarian Cancer. Completed, enrolled 190 participants across 55 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesBrazil, France, Italy, Netherlands, Norway, Russia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2009
Enrollment StartJun 25, 2009
Primary CompletionJul 31, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.0 years ago

Interventions

Bevacizumabdrug

Bevacizumab was supplied as a sterile solution for infusion.

Paclitaxeldrug

Paclitaxel was supplied locally in commercial batches.

Carboplatindrug

Carboplatin was supplied locally in commercial batches.