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