PHASE I TRIAL OF SEQUENTIAL TOMUDEX AND 5-FLUOROURACIL IN SUBJECTS WITH ADVANCED COLORECTAL CARCINOMA
OBJECTIVES: I. Determine the maximum tolerated dose of raltitrexed when administered with
fluorouracil in patients with advanced colorectal carcinoma. II. Determine the toxicity and
safety of this regimen in these patients. III. Assess, in a preliminary manner, the
antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of raltitrexed. Patients receive raltitrexed IV
over 15 minutes followed 24 hours later by fluorouracil IV. Treatment continues every 3
weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of raltitrexed until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose immediately preceding that at which 2 of 6
patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the
MTD. Patients are followed for 6 weeks.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20
months.
Interventional
Primary Purpose: Treatment
Gary K. Schwartz, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
95-021
NCT00002828
April 1995
November 2001
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |