Colorectal Cancer Clinical Trial
Official title:
Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
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.
;
Masking: Open Label, Primary Purpose: Treatment
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