NCT00176774

Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma

A Pilot Trial of Irinotecan, 5-Fluorouracil, and Leucovorin Combined With the Anti-Angiogenesis Agent Tetrathiomolybdate in Metastatic Colorectal Carcinoma (UMCC 0075)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
DRUG	5-Fluorouracil	Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
DRUG	Leucovorin	Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.
DRUG	Tetrathiomolybdate	one 40 mg oral (by mouth) dose of TM three times a day with meals and one 60 mg oral dose (without food) at bedtime beginning at bedtime on day 1 of your first 6-week cycle of treatment. The between meal dose must be taken at least one hour before or one hour after a meal.

Timeline

• Start date: 2001-02-01
• Primary completion: 2004-02-01
• Completion: 2004-04-01
• First posted: 2005-09-15
• Last updated: 2012-02-07

Locations

1 site across 1 country: United States