Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

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.

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