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Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal cancer.
OBJECTIVES: Primary * Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with celecoxib, capecitabine, and irinotecan. Secondary * Determine the time to progression in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine the overall survival of patients treated with this regimen. * Determine the time to treatment failure in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral celecoxib twice daily on days -7 to 21 during course 1 and on days 1-21 in all subsequent courses. Patients also receive oral capecitabine twice daily on days 1-14 and irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response after 4 courses may temporarily discontinue treatment for no more than 4 weeks. After completion of study treatment, patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 21-44 patients will be accrued for this study within 7-18 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Start Date
January 1, 2002
Primary Completion Date
March 1, 2007
Completion Date
August 1, 2007
Last Updated
April 8, 2013
capecitabine
DRUG
celecoxib
DRUG
irinotecan hydrochloride
DRUG
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
NCT04704661
NCT06696768
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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