Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib works in treating patients with metastatic pancreatic cancer.
Drug: Gemcitabine Hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer|
- Overall Survival at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2003|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + Celecoxib
Oral celecoxib twice daily on days 1-28. Gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
Other Name: CelebrexDrug: Gemcitabine Hydrochloride
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
- 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 thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 8 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068432
|United States, Arkansas|
|Hembree Mercy Cancer Center at St. Edward Mercy Medical Center|
|Fort Smith, Arkansas, United States, 72913|
|United States, Florida|
|M.D. Anderson Cancer Center - Orlando|
|Orlando, Florida, United States, 32806-2134|
|United States, Georgia|
|CCOP - Atlanta Regional|
|Atlanta, Georgia, United States, 30342-1701|
|United States, Illinois|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Missouri|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|CCOP - Cancer Research for the Ozarks|
|Springfield, Missouri, United States, 65807|
|United States, Ohio|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, Oregon|
|CCOP - Columbia River Oncology Program|
|Portland, Oregon, United States, 97225|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Wisconsin|
|All Saints Cancer Center at All Saints Healthcare|
|Racine, Wisconsin, United States, 53405|
|Principal Investigator:||Henry Q. Xiong, MD, PhD||M.D. Anderson Cancer Center|