NCT00127036

Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)

A Multicenter Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma
• Colon Cancer

Interventions

Type	Name	Description
DRUG	XELOX	XELOX: Oxaliplatin 130 mg/m\^2 intravenously (IV); Capecitabine 825 mg/m\^2 by mouth (po)
DRUG	XELIRI	XELIRI: Irinotecan 240 mg/m\^2 IV; Capecitabine 825 mg/m\^2 by mouth (po)
DRUG	Bevacizumab	7.5 mg/kg intravenously (IV)

Timeline

• Start date: 2003-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-08-05
• Last updated: 2017-03-23
• Results posted: 2012-04-05

Locations

12 sites across 1 country: United States