Colorectal Cancer Clinical Trial
Official title:
Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of tocladesine in treating patients who
have recurrent or progressive metastatic colorectal cancer.
OBJECTIVES:
- Determine the maximum tolerated dose of tocladesine in patients with recurrent or
progressive metastatic colorectal cancer.
- Determine the qualitative and quantitative toxicity of this drug in these patients.
- Assess any therapeutic activity in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive tocladesine IV continuously on days 1-5 and 8-12. Treatment repeats every
21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, up to 14 additional
patients are treated at this dose level.
PROJECTED ACCRUAL: A total of 3-38 patients will be accrued for this study.
;
Primary Purpose: Treatment
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