Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
- 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.
- Determine the objective response and stabilization rate in patients treated with this
- 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
Time to progression
May Mabro, MD
United States: Federal Government