Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
- Determine the objective response rate in patients with locally recurrent or metastatic
colorectal cancer treated with celecoxib, capecitabine, and irinotecan.
- 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
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
Masking: Open Label, Primary Purpose: Treatment
Response rate by RECIST criteria at every other course
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|