Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine)
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: oral azacitidine; Observation
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To improve progression free survival in high risk patients with resected pancreatic
      adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in
      CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of
      adjuvant therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form.

          -  Age greater than or 18 years at the time of signing the 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 + 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 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 (CT, PETCT or MRI) evaluating
             chest, abdomen, and pelvis within 28 days of enrollment on the study.

          -  Life expectancy of greater than 12 weeks

          -  ECOG performance status of less than or equal to 1 at study entry

          -  Subjects must have normal organ and marrow function

          -  Free of prior malignancies for greater than or equal to 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 β-hCG pregnancy
             test at screening.

          -  Subjects must have < Grade 2 pre-existing peripheral neuropathy (per 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 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.