NCT00021268

Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer

Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	tocladesine

Timeline

• Start date: 2001-04-01
• First posted: 2003-09-10
• Last updated: 2013-08-02

Locations

1 site across 1 country: United States