Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine)

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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 CA19-9 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. 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 CA19-9 elevation can enroll any time after adjuvant therapy has completed. Arm A, the treatment arm, will be started on CC-486. Arm B, the control arm, will receive no additional therapy. In both arms, CA19-9 will be followed and CT scans (or MRI, if clinically indicated) will be done every three months. When patients have visible disease recurrence on imaging, CC-486 will be stopped and both groups will start first-line chemotherapy.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression-free Survival [25 months]. Median, months (95% Confidence Interval). Arm A: CC-486 (n=23): 9.2 (4.1 to 20.9); Arm B: Observation (n=25): 8.9 (3.4 to 24.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Response Rate as Assessed by Number of Participants With Partial or Complete Response [11 months]. Count Of Participants, Participants. Arm A: CC-486 (n=13): 1; Arm B: Observation (n=13): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [47 months]. Median, months (95% Confidence Interval). Arm A: CC-486 (n=24): 33.8 (12.8 to 47.6); Arm B: Observation (n=25): 26.4 (17.8 to 46.7).