Colorectal Cancer Clinical Trial
Official title:
Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and
oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing
or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line
therapy in treating patients who have 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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