A Study of Mitomycin C, Irinotecan, and Cetuximab
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: Pathologic diagnosis of colorectal cancer. Clinical and/or radiologic evidence of metastatic disease. One previous systemic treatment for metastatic disease. Age > 18. Presence of at least one measurable lesion. Adequate hematopoetic (absolute neutrophil count > 1500/mm3, platelet count > 100,000/mm3), renal (serum creatinine < 1.5 mg/dl), and hepatic function (bilirubin < 1.5 and transaminases < 5.0 x upper normal limit). ECOG performance status 0-2. Life expectancy > 3 months. Patients must be informed of the investigational nature of this study and provide written informed consent in accordance with the institutional and federal guidelines prior to the initiation of therapy. Exclusion Criteria: No recognized brain metastasis. No previous treatment with mitomycin C or cetuximab. No other systemic malignancy requiring treatment within the past one year. Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method. Patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
Sites / Locations
- University of Michigan Comprehensive Cancer Center
Arms of the Study
Arm 1
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.