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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00271011 |
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.
Condition | Intervention | Phase |
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Colorectal Cancer (CRC) |
Drug: Mitomycin C Drug: Cetuximab Drug: Irinotecan. |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer |
Estimated Enrollment: | 39 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cancer Answer Line | 1-800-865-1125 |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48104 | |
Contact: Cancer Answer Line 800-865-1125 | |
Principal Investigator: Mark Zalupski, M.D. |
Principal Investigator: | Mark Zalupski, M.D. | University of Michigan Cancer Center |
Responsible Party: | University of Michigan Health Systems ( Dr. Mark Zalupski ) |
Study ID Numbers: | UMCC 2005-060, HUM 00000749 |
Study First Received: | December 27, 2005 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00271011 |
Health Authority: | United States: Institutional Review Board |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Cetuximab Intestinal Diseases Rectal Diseases |
Mitomycins Intestinal Neoplasms Digestive System Diseases Mitomycin Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic Alkylating Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |