Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||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|
- Complete response rate [ Designated as safety issue: No ]
- Objective response rate [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Time to response [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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 regimen.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556413
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||Marc Ychou, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|