CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 820 enrolled
Drug / intervention
Chemotherapy +1 moredrug
Likely dose
Bevacizumab 5 mg/kgfrom 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/NCT00700102
NCT00700102Phase 3Completed

A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

Hoffmann-La Roche·interventional·Posted Jun 18, 2008·Updated Jul 30, 2015

In Brief

A Phase 3 clinical trial evaluating Chemotherapy and Bevacizumab for Colorectal Cancer. Completed, enrolled 820 participants across 300 sites in 15 countries.

Detailed Summary

This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Czechia, Denmark, Estonia, Finland, France, Germany, Netherlands, Norway, Portugal, Saudi Arabia, Spain, Sweden, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartFeb 1, 2006
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 18.0 years ago

Interventions

Chemotherapydrug

As prescribed

Bevacizumabdrug

Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.