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