Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.
OBJECTIVES:
- 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
day 1.
Courses repeat every 14 days in both arms in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, after courses 4 and 6, and every 6 courses
thereafter.
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Aimery de Gramont, MD
Study Chair
Hopital Saint Antoine
United States: Federal Government
CDR0000068282
NCT00006468
January 2000
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