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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
1 to 2 years
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center||Lutherville, Maryland|