Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00258232
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate by RECIST criteria at every other course
- Secondary Outcome Measures
Name Time Method Overall survival Time to treatment failure Time to progression Toxicity
Trial Locations
- Locations (3)
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
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States