Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer
This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||C-2424: Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer|
- To determine the objective response rate to the combination of celecoxib, capecitabine, and irinotecan in patients with metastatic colorectal cancer.
- To evaluate the time to progression of metastatic colorectal cancer after treatment with celecoxib, capecitabine, and irinotecan.
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||March 2008|
|Estimated Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230399
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mark Zalupski, M.D.||University of Michigan Cancer Center|