Colorectal Cancer Clinical Trial
Official title:
PHASE I TRIAL OF SEQUENTIAL TOMUDEX AND 5-FLUOROURACIL IN SUBJECTS WITH ADVANCED COLORECTAL CARCINOMA
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.
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.
;
Primary Purpose: Treatment
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