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A Phase II Trial to Improve Outcomes in Patients With Resected Pancreatic Adenocarcinoma at High Risk for Recurrence Using Epigenetic Therapy

Phase 2
18 Years
Not Enrolling
Resected Pancreatic Adenocarcinoma

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Trial Information

A Phase II Trial to Improve Outcomes in Patients With Resected Pancreatic Adenocarcinoma at High Risk for Recurrence Using Epigenetic Therapy

This trial is for patients with resected pancreatic adenocarcinoma who have concluded
adjuvant therapy or were deemed unable to receive adjuvant therapy with an elevated CA 19-9
or node positive or margin positive disease. CA 19-9 elevation is defined as two levels >
the institutional upper limit of normal (ULN) taken at least 2 weeks apart. These levels
should be measured after adjuvant therapy has concluded or upon the decision that adjuvant
therapy will not be offered. Patients will be randomized to one of two arms. Randomization
must occur within 3 months of finishing adjuvant therapy or from the decision that adjuvant
therapy will not be offered. Group A, the treatment arm, will be started on CC-486 (oral
azacitidine). Group B, the control arm, will receive no additional therapy. CA 19-9 will
be followed monthly and CT scans every 2 months in both arms. When patients have visible
disease recurrence on imaging, CC-486 will be stopped and both groups will start first-line
chemotherapy (possibly abraxane or gemcitabine).


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.

To improve response rates to first-line chemotherapy (partial and complete response) after
recurrence in patients treated with CC-486 after completing adjuvant therapy.

To improve overall survival in patients with resected pancreatic adenocarcinoma treated with

To evaluate resected pancreatic cancer tissue and biopsies at time of recurrence for
epigenetic and genetic alterations to determine the pharmacodynamic effects of CC-486.

To evaluate resected pancreatic cancer tissue to identify predictive signatures of possible
recurrence and the benefit of hypomethylating therapy.

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 must be able to undergo randomization within 3 months of finishing adjuvant
therapy or the decision that they are unable to take adjuvant therapy.

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

The primary endpoint of the trial is to demonstrate an increase in the progression free survival (PFS) in resected pancreatic cancer patients treated with CC-486 (oral azacitidine), using RECIST.

Outcome Time Frame:

1 to 2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Resected Pancreatic Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Sidney Kimmel Comprehensive Cancer Center Lutherville, Maryland