Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-2003-0288 | Other Identifier | UT MD Anderson Cancer Center | |
| NCI-6167 | |||
| CDR0000322827 | Registry Identifier | NCI PDQ |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Celecoxib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 6 months | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | 6 months |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Henry Q. Xiong, MD, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Fort Smith | Arkansas | 72913 | United States | ||
Not provided
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine Hydrochloride | Drug | Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks. |
|
|
| M.D. Anderson Cancer Center - Orlando |
| Orlando |
| Florida |
| 32806-2134 |
| United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin | 53405 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided