Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer

Inclusion criteria

• Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma.
• Patients must have clinical/radiologic evidence of metastatic disease (stage IV).
• Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, provided that the last day of therapy was at least 6 months prior to starting treatment.
• Patients must have performance status of 0-2 on the SWOG scale.
• Patients must have an estimated life expectancy of at least 12 weeks.
• Patients must have adequate bone marrow function: absolute neutrophil count >1,500/cmm, platelet count >100,000/cmm.
• Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
• Patients must practice effective birth control while receiving treatment.

Exclusion criteria

• Patients with endocrine tumors or lymphoma of the pancreas.
• Patients with locally advanced pancreatic cancer.
• Patients with a proven history (radiographic and/or endoscopic) of peptic ulcer or esophageal erosions within one year of enrollment onto the study.
• Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
• History of active central nervous system (CNS) metastases.
• Inadequate liver function (bilirubin >3.0 mg/dL); transaminases (AST/ALT) >3 times upper limit of institutional normal.
• Inadequate renal function (creatinine >1.5 mg/dL).
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
• Unresolved bacterial infection requiring treatment with antibiotics.
• Pregnant or lactating women may not participate in the study.
• Patients who have allergy to any of the study drugs or sulfa drugs.
• Patients infected with HIV-1 virus because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.