Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer
- Determine the tumor response rate in patients with metastatic colorectal cancer treated
with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line
- Determine the time to tumor progression, time to treatment failure, and overall
survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
- Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia,
diarrhea, or neutropenia) or response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and
leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every
3 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each chemotherapy course, and at the end of
Patients are followed every 3 months until 5 years after registration.
PROJECTED ACCRUAL: A total of 50-105 patients will be accrued for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
Charles Erlichman, MD
United States: Federal Government