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Brief Title: Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)
Official Title: A Multicenter Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)
Study ID: NCT00127036
Brief Summary: The purpose of this study is to determine if the investigators can predict the sensitivity or resistance of colon cancer to the two available first line chemotherapy agents.
Detailed Description: Colorectal cancer is the third largest cause of cancer mortality in the United States. The treatment of metastatic colorectal cancer is undergoing rapid improvement. Currently, there are two major chemotherapy regimens, which can both be combined with anti-angiogenesis treatment. These regimens are 5-Fluorouracil (5-FU) + irinotecan and 5-FU + oxaliplatin. Each therapy has roughly similar rates of response, but it is unclear which specific therapy would benefit which patients. The advent of genome wide expression analysis provides a tool to analyze these differences. In the microarray analysis of colon cancer outcome trial, sponsored by the National Institutes of Health (NIH) and Moffitt Cancer Center, patients with newly diagnosed metastatic colon cancer are biopsied and samples are preserved in ribonucleic acid (RNA) later. Patients are then randomized to either one of two state of the art regimens: capecitabine + irinotecan + avastin (bevacizumab) or capecitabine + oxaliplatin + avastin. Response to chemotherapy, time to progression, and overall survival are end points of this trial. Once accrual of patients has been met, the investigators will compare genome wide expression patterns for each group.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
North Broward Medical Center, Deerfield Beach, Florida, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Florida Cancer Specialists, Ft. Myers, Florida, United States
Center for Cancer Care & Research - Watson Clinic, Lakeland, Florida, United States
Fawcett Memorial Hospital, Port Charlotte, Florida, United States
Martin Memorial, Stuart, Florida, United States
Tallahassee Memorial Hospital, Tallahassee, Florida, United States
Bay Area Oncology, Tampa, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Space Coast Medical Associates, Titusville, Florida, United States
St. Joseph's Candler Health System, Savannah, Georgia, United States
Southeast Nebraska Cancer Center, Lincoln, Nebraska, United States
Name: Jonathan Strosberg, MD
Affiliation: H. Lee Moffitt Cancer Center & Research Institute / University of South Florida
Role: PRINCIPAL_INVESTIGATOR