A Phase I/II Study of Eniluracil Plus Oral 5-Fluorouracil Combined With Oxaliplatin (FOX-E) in Patients With Previously-Treated Colorectal Cancer
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and recommended
phase II dose of eniluracil, fluorouracil, and oxaliplatin in patients with previously
treated advanced colorectal cancer. II. Determine the response rate in patients treated with
OUTLINE: This is a dose escalation study of eniluracil and fluorouracil. Patients receive
oral eniluracil and oral fluorouracil twice daily on days 1-21. Patients receive oxaliplatin
IV over 2 hours on days 1 and 15. Treatment continues every 4 weeks in the absence of
disease progression or unacceptable toxicity. Patients with complete response are treated
with 2 more courses and then therapy is stopped. Cohorts of 3-6 patients receive escalating
doses of eniluracil and fluorouracil until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose limiting toxicity. The recommended phase II dose (RPTD) is defined as 1 dose level
below the MTD. Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for phase I of the study, and an
additional 27-40 patients will be accrued for phase II of the study.
Primary Purpose: Treatment
Howard S. Hochster, MD
New York University School of Medicine
United States: Federal Government
|Kaplan Cancer Center
|New York, New York 10016