Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.
- Compare the efficacy of intermittent high-dose oxaliplatin in combination with a
simplified bimonthly regimen of leucovorin calcium (LV) and fluorouracil (5-FU) vs
standard dose oxaliplatin in combination with the standard bimonthly regimen of LV and
5-FU in patients with metastatic colorectal cancer.
- Determine the time to treatment failure, tolerance, response rate, and overall survival
in patients treated with these 2 regimens.
- Compare quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to treatment center, performance status (0-1 vs 2), and number of metastatic sites
(1 vs more than 1). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1, and leucovorin calcium IV
over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2.
- Arm II: Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours followed
by 5-FU IV over 46 hours beginning on day 1 for courses 1-6 and 19-24. For courses
7-18, patients receive leucovorin calcium IV followed by 5-FU IV as above beginning on
Courses repeat every 14 days in both arms in the absence of disease progression or
Quality of life is assessed at baseline, after courses 4 and 6, and every 6 courses
Patients are followed monthly for 3 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 460 patients (230 per treatment arm) will be accrued for this
study within 18 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Aimery de Gramont, MD
Hopital Saint Antoine
United States: Federal Government