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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00068432 |
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 | Intervention | Phase |
Pancreatic Cancer |
Drug: celecoxib Drug: gemcitabine hydrochloride |
Phase II |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
Drug Information available for: | Gemcitabine hydrochloride Gemcitabine Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide |
Study Type: | Interventional |
Study Design: | Treatment, 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 |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 - Cancer Research for the Ozarks | |||||
Springfield, Missouri, United States, 65807 | |||||
CCOP - Kansas City | |||||
Kansas City, Missouri, United States, 64131 | |||||
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 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Henry Q. Xiong, MD, PhD | M.D. Anderson Cancer Center |
Investigator: | Brenda T. Douglas | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000322827, MDA-2003-0288, NCI-6167 |
First Received: | September 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00068432 |
Health Authority: | United States: Federal Government |
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