A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer
- Determine the overall survival at 6 months in patients with metastatic pancreatic
cancer treated with gemcitabine and celecoxib.
- Determine the objective tumor response, progression-free survival, and median survival
of patients treated with this regimen.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive gemcitabine IV over 65 minutes on days 1, 8, and 15 and oral celecoxib
twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression
or unacceptable toxicity.
Patients are followed monthly for 6 months from study entry and then every 3 months
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 8 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival at 6 months
Henry Q. Xiong, MD, PhD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Atlanta Regional||Atlanta, Georgia 30342-1701|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|M.D. Anderson Cancer Center - Orlando||Orlando, Florida 32806|
|Hembree Mercy Cancer Center at St. Edward Mercy Medical Center||Ft. Smith, Arkansas 72903|
|All Saints Cancer Center at All Saints Healthcare||Racine, Wisconsin 53405|