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

This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable
pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery
with curative intent for 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