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A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced 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.
OBJECTIVES: * 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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Start Date
December 1, 2003
Primary Completion Date
July 1, 2005
Completion Date
July 1, 2005
Last Updated
October 31, 2018
28
ACTUAL participants
Celecoxib
DRUG
Gemcitabine Hydrochloride
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT05053971
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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