Phase II Study Evaluating the Efficacy and Safety of cétuximab Associated With the Protocol FOLFIRINOX (LV5FU Simplified Combined With Irinotecan and Oxaliplatin) in the First Line Treatment in Patients With Metastatic Colorectal Cancer Expressing EGFR or Not
- Determine the complete response rate in patients with metastatic colorectal cancer
treated with cetuximab and FOLFIRINOX chemotherapy comprising oxaliplatin, irinotecan
hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.
- Determine the objective response rate in patients treated with this regimen.
- Assess the tolerability of this regimen in these patients.
- Determine the time to response and time to progression in patients treated with this
- Determine the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1 and 8. Patients also receive
FOLFIRINOX chemotherapy comprising oxaliplatin IV over 2 hours, irinotecan hydrochloride IV
over 30-90 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 15 days for up to 12
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Allocation: Non-Randomized, Primary Purpose: Treatment
Complete response rate
Marc Ychou, MD, PhD
Centre Val d'Aurelle - Paul Lamarque
United States: Federal Government