Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
NCT ID: NCT00068432
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2003-12-31
2005-07-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib works in treating patients with metastatic pancreatic cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Celecoxib
Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
Gemcitabine Hydrochloride
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
Interventions
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Celecoxib
Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
Gemcitabine Hydrochloride
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed metastatic pancreatic cancer
* Radiographic evidence of disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Gastrointestinal
* No history of peptic ulcer disease
* No gastrointestinal bleeding within the past 3 months
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reactions to compounds of similar chemical or biological composition to study drugs or to sulfonamides
* No prior allergic reaction, asthma, or urticaria after taking aspirin or NSAIDs
* No ongoing or active infection
* No other uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for metastatic pancreatic cancer
* More than 6 months since prior neoadjuvant or adjuvant chemoradiotherapy (including gemcitabine) for pancreatic cancer
Endocrine therapy
* Not specified
Radiotherapy
* See Chemotherapy
* More than 6 months since prior radiotherapy
Surgery
* Not specified
Other
* More than 30 days since prior investigational agents
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
* No other concurrent cyclo-oxygenase-2 (COX-2) inhibitors (e.g., rofecoxib)
* Concurrent acetaminophen-containing medications or low-dose aspirin (up to 325 mg/day) for cardiac prophylaxis allowed
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Henry Q. Xiong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-2003-0288
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-6167
Identifier Type: -
Identifier Source: secondary_id
CDR0000322827
Identifier Type: REGISTRY
Identifier Source: secondary_id
2003-0288
Identifier Type: -
Identifier Source: org_study_id
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