A Study of Mitomycin C, Irinotecan, and Cetuximab
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.
Colorectal Cancer (CRC)
Drug: Mitomycin C
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer|
- response [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- toxicity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2005|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Mitomycin C, Irinotecan and Cetuximab
Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2.
|Drug: Mitomycin C Drug: Cetuximab Drug: Irinotecan.|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48104|
|Principal Investigator:||Mark Zalupski, M.D.||University of Michigan Cancer Center|