Multicenter Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone As Adjuvant Treatment Of Stage III Colon Cancer
- Compare the disease-free survival at 3 years of patients with resected stage III
colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or
- Compare the disease-free and overall survival at 5 years of patients treated with these
- Compare the safety profiles of these treatment regimens in these patients.
- Compare the quality-adjusted survival of patients treated with these regimens.
- Correlate the expression of putative prognostic markers (thymidylate synthase,
telomerase, topoisomerase) with disease-free and overall survival of patients treated
with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Patients receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 2 hours,
and fluorouracil IV over 24 hours weekly for 6 weeks. Courses repeat every 7 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.
- As an alternative schedule, patients may receive irinotecan IV over 30-90 minutes and
day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days
1 and 2 every 2 weeks for 6 weeks. Treatment repeats every 6 weeks for up to 4 courses
in the absence of disease progression or unacceptable toxicity.
- Patients receive leucovorin calcium and fluorouracil as in arm I. Quality of life may
be assessed at baseline; prior to courses 2, 3, and 4; and at 1, 3, and 6 months.
Patients are followed every 3 months for 3 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 1800 patients (900 per arm) will be accrued for this study
within 24 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Eric Van Cutsem, MD, PhD
United States: Federal Government