Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-fluorouracil, Folinic Acid, Irinotecan and Bevacizumab as First-line Treatment in Patients With Metastatic Colorectal Cancer
- Determine the efficacy of bevacizumab, irinotecan hydrochloride, leucovorin calcium,
and fluorouracil, in terms of partial or complete response, in patients with
unresectable metastatic colorectal cancer.
- Determine the duration of response in patients treated with this regimen.
- Determine the overall survival and progression-free survival of patients treated with
- Determine the tolerability of this regimen in these patients.
- Assess the pharmacogenetics and change in genetic polymorphisms susceptible to
modification by this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2
hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV over 46 hours
beginning on day 1. Treatment repeats every 2 weeks in the absence of disease progression or
Blood and tissue samples are collected periodically for pharmacogenetic and genetic
PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.
Allocation: Non-Randomized, Primary Purpose: Treatment
Partial or complete response rate
Yves Becouarn, MD
United States: Federal Government