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