Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study
- Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI
and bevacizumab therapy.
- Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment.
- Evaluate progression-free survival and overall survival.
- Determine the time to treatment failure.
- Evaluate the quality of life (EuroQOL EQ5D questionnaire).
- Explore the prognostic factors associated with the tolerability and efficacy of this
OUTLINE: This is a multicenter study. Patients are stratified according to genotype
(UCT1A1*1/ UCT1A1*1 vs UCT1A1*1/ UCT1A1*28).
Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90
minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
Treatment repeats every 2 weeks in the absence of disease progression or unacceptable
Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the
completion of study therapy.
After completion of study therapy, patients are followed every 2-3 months.
Masking: Open Label, Primary Purpose: Treatment
Objective response at 6 months by RECIST
Federation Francophone de Cancerologie Digestive