drugset / Trial / NCT00271011

A Study of Mitomycin C, Irinotecan, and Cetuximab

NCT00271011

Phase 2 Terminated 13 enrolled University of Michigan Rogel Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned. This study will also evaluate any rash that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C, Irinotecan, and Cetuximab.

Timeline

Start
2005-12
Primary completion
2008-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2
Subject Irinotecan Small molecule 110 mg/m2
Subject Irinotecan Small molecule 140 mg/m2
Subject Mitomycin C Other / unclassified 7 mg/m2

Indications