CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 247 enrolled
Drug / intervention
Bevacizumab +4 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/NCT00252564
NCT00252564Phase 3Completed
CompareCT.gov

Randomized PhIII Trial of Cetuximab, Bevacizumab & Biweekly Infusional 5FU/Leucovorin (FOLF-CB) vs. Oxaliplatin, Bevacizumab, & Biweekly Infusional 5FU/Leucovorin (Bev-FOLFOX) in First Line Treatment of Metastatic Colorectal Cancer

US Oncology Research·interventional·Posted Nov 11, 2005·Updated Feb 15, 2019

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Oxaliplatin, and 3 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 247 participants across 82 sites.

Detailed Summary

The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Memorial Sloan Kettering Cancer Center, Prologue Research International

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 11, 2005
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2007
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.6 years ago

Interventions

Bevacizumabdrug

5 mg/kg over 30 minutes on Days 1 and 15

Oxaliplatindrug

85 mg/m2 on Days 1 and 15

Leucovorindrug

400 mg/m2 on Days 1 and 15

Fluorouracildrug

400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)

Cetuximabdrug

400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour