Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer
OBJECTIVES:
Primary
- Determine the tumor response rate in patients with metastatic colorectal cancer treated
with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line
treatment.
Secondary
- 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
treatment.
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Charles Erlichman, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000357571
NCT00080951
March 2004
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