Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically removed.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE I TRIAL OF SEQUENTIAL TOMUDEX AND 5-FLUOROURACIL IN SUBJECTS WITH ADVANCED COLORECTAL CARCINOMA|
|Study Start Date:||April 1995|
|Study Completion Date:||November 2001|
|Primary Completion Date:||November 2001 (Final data collection date for primary outcome measure)|
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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Gary K. Schwartz, MD||Memorial Sloan-Kettering Cancer Center|