drugset / Trial / NCT00176774

Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma

NCT00176774

Phase 2 Completed 24 enrolled University of Michigan Rogel Cancer Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM) combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV). This study will evaluate the safety and tolerability of the combination of these drugs when they are used in the treatment of metastatic colorectal cancer. This is a pilot clinical trial which will be studying the reactions of the patient's body and tumor to the experimental treatment described above. The purpose of this study is to find out what kind of side effects this experimental treatment causes and see how often these side effects occur.

Timeline

Start
2001-02
Primary completion
2004-02
Completion
2004-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Tetrathiomolybdate Unknown 40 mg Oral
Subject Tetrathiomolybdate Unknown 60 mg Oral
Background Irinotecan Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background fluorouracil Small molecule Intravenous

Indications