A Phase II Trial of Eloxatin in Combination With 5-Fluorouracil and Leucovorin in Patients With Advanced Colorectal Carcinoma
OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined
with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the
colon or rectum.
OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10
minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive
oxaliplatin IV over 2 hours prior to leucovorin calcium and fluorouracil on days 1, 15, 29,
and 43. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression
or unacceptable toxicity. Patients with stable or responding disease may receive additional
courses upon approval by the sponsor. Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Primary Purpose: Treatment
Howard S. Hochster, MD
New York University School of Medicine
United States: Federal Government
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|