A Multicenter Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier
Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).
30 Days After End of Treatment - Average of 6 Months
No
Jonathan Strosberg, MD
Principal Investigator
H. Lee Moffitt Cancer Center & Research Institute / University of South Florida
United States: Food and Drug Administration
MCC-13449
NCT00127036
October 2003
December 2010
Name | Location |
---|---|
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Tallahassee Memorial Hospital | Tallahassee, Florida 32308 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
Bay Area Oncology | Tampa, Florida 33607 |
Fawcett Memorial Hospital | Port Charlotte, Florida 33952 |
North Broward Medical Center | Dearfield Beach, Florida 33064-3596 |
Space Coast Medical Associates | Cocoa Beach, Florida 32931 |
Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
Center for Cancer Care & Research - Watson Clinic | Lakeland, Florida 33805 |
Martin Memorial | Stuart, Florida 34994 |
St. Joseph's Candler Health System | Savannah, Georgia 31405 |