Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00068432|
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : January 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Celecoxib Drug: Gemcitabine Hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
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: Celebrex
Drug: Gemcitabine Hydrochloride
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
- Overall Survival at 6 months [ Time Frame: 6 Months ]
- Overall response rate [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|