Azacitidine in Treating Patients with Pancreatic Cancer That Has Been Removed by Surgery

Inclusion Criteria

• Understand and voluntarily sign an informed consent form
• Able to adhere to the study visit schedule and other protocol requirements
• Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection
• Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy; although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy +/- radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria
• Subjects enrolled due to node positive (+) disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy; patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed
• All previous cancer therapy including radiation, chemotherapy, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
• Subjects must either have a CA 19-9 value > the institutional upper limit of normal (ULN) on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19-9 level
• Subjects must be free of visible disease on imaging (computed tomography [CT], positron emission tomography CT [PETCT] or magnetic resonance imaging [MRI]) evaluating chest, abdomen, and pelvis within 28 days of enrollment on the study
• Life expectancy of greater than 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 at study entry
• Absolute neutrophil count >= 1500/mm^3
• Leukocytes >= 3,000/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin > 9.0 g/dL
• Serum creatinine levels =< 2 mg/dL
• Serum bilirubin levels =< 1.5 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
• Alkaline phosphatase =< 2.5 x ULN
• Free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
• Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel; all men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment
• Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening
• Subjects must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])

Exclusion Criteria

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Pregnant or breastfeeding women
• Use of any other chemotherapy, radiotherapy, or experimental drug or therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment on study or those who have not recovered from adverse events >= grade 1 due to agents administered more than 4 weeks earlier except for stable grade 2 neuropathy
• Subjects may not receive any other concomitant investigational agents
• Known or suspected hypersensitivity to 5-azacitidine or mannitol
• Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type B or C; HIV patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine