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Brief Title: A Study of Mitomycin C, Irinotecan, and Cetuximab
Official Title: A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer
Study ID: NCT00271011
Brief 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.
Detailed Description: We propose a phase II trial which combines mitomycin C, irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated K-Ras. The goals of this investigation are to develop an effective systemic therapy for previously treated patients with CRC with wild type K-Ras, to further explore the relationship of mitomycin C induced topoisomerase 1 gene expression and response to irinotecan, and to define and characterize the biology of cetuximab induced skin rash.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Name: Mark Zalupski, M.D.
Affiliation: University of Michigan Rogel Cancer Center
Role: PRINCIPAL_INVESTIGATOR