Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer

Inclusion Criteria: * Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma * Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry * Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer * Karnofsky performance status of greater than or equal to 70% * Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1 * Women of child bearing age must have negative serum pregnancy test prior to treatment Exclusion Criteria: * Known central nervous system tumor involvement * Evidence of other active malignancy requiring treatment * Clinically significant heart disease * Active serious systemic disease, including active bacterial or fungal infection * Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary * Prior surgery with curative intent for pancreatic cancer * Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed * Breast feeding, pregnant, or likely to become pregnant during the study * known or suspected hypersensitivity to azacitidine or mannitol