RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
OBJECTIVES: Primary * Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan. Secondary * Determine the objective response and stabilization rate in patients treated with this regimen. * Determine the time to treatment failure in patients treated with this regimen. * Determine the duration of response in patients treated with this regimen. * Determine overall survival rate in patients treated with this regimen. * Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Hopital Drevon
Dijon, France
Centre Hospital Universitaire Hop Huriez
Lille, France
Clinique Saint Jean
Lyon, France
Time to progression
Time to death from progression
Objective response
Stabilization rate
Time to treatment failure
Duration of response
Overall survival rate
Incidence of grade 3 or 4 toxicity
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