Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil (FOLFIRI) Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine (XELIRI) in Patients With Unresectable Metastatic Colorectal Cancer [ACCORD]
- Compare the progression-free survival at 6 months in patients with unresectable
metastatic colorectal cancer treated with first-line therapy comprising bevacizumab and
irinotecan hydrochloride, leucovorin calcium, and fluorouracil (FOLFIRI) vs bevacizumab
and irinotecan hydrochloride and capecitabine (XELIRI).
- Compare the toxicities of these regimens in these patients.
- Compare the objective response rate and duration of response in patients treated with
- Compare the tumor control in patients treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to participating center, WHO performance status (0 or 1 vs 2), age (< 65 years vs
≥ 65 years), and number of metastatic sites (1 vs ≥ 2). Patients are randomized to 1 of 2
- Arm I: Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV
over 90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV
continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 12
courses in the absence of disease progression or unacceptable toxicity. Patients may
then continue to receive bevacizumab alone every 2 weeks in the absence of disease
- Arm II: Patients receive bevacizumab IV over 30-90 minutes and irinotecan hydrochloride
IV over 90 minutes on day 1 and oral capecitabine on days 1-14. Treatment repeats every
3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients may then continue to receive bevacizumab alone every 3 weeks in the absence of
Quality of life is assessed periodically.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
Michel Ducreux, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government