Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer.
Drug: FOLFIRI regimen
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||January 2001|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
- 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 without irinotecan.
- Compare the disease-free and overall survival at 5 years of patients treated with these regimens.
- 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.
|Allgemeines Krankenhaus der Stadt Wien|
|Vienna (Wien), Austria, A-1090|
|Leuven, Belgium, B-3000|
|National Cancer Institute of Egypt|
|Paris, France, 75651|
|Paris, France, 75970|
|Hamburg, Germany, D-20246|
|Ospedali Riuniti di Bergamo|
|Bergamo, Italy, 24100|
|Universita Degli Studi di Firenze - Policlin. di Careggi|
|Firenze (Florence), Italy, 1 (50-134)|
|Ospedale San Carlo Borromeo|
|Milano (Milan), Italy, 20153|
|Azienda Ospedaliera S. Maria|
|Terni, Italy, 05100|
|Universita Degli Studi di Udine|
|Udine, Italy, 33100|
|Instituto Portugues de Oncologia do Porto|
|Porto, Portugal, 4200|
|Hospital Universarito "Reina Sofia"|
|Cordoba, Spain, 14004|
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Eric Van Cutsem, MD, PhD||U.Z. Gasthuisberg|