A Phase 2 interventional study of Celecoxib and Gemcitabine Hydrochloride in Pancreatic Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 11 sites in United States. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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:
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 28 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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.
Drug: Celecoxib · Drug: Gemcitabine Hydrochloride
Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
Also known as: Celebrex
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
Also known as: Gemcitabine, Gemzar
Overall Survival at 6 months
Time frame: 6 Months
Overall response rate
Time frame: 6 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center