Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Gemcitabine Hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine + Celecoxib<br>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<br>* Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.<br>* Other names: Celebrex;Drug: Gemcitabine Hydrochloride<br>* Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival at 6 months |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pancreatic cancer, stage IV pancreatic cancer