Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan
- 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
Lee S. Rosen, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|