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

Summary

Participation Requirements

Description

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...

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. 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. Group A, the treatment arm, will be started on CC-486 (oral azacitidine). Group B, the control arm, will receive no additional therapy. Both Arms will evaluate CA 19-9 and have CT scans every 3 months. 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). GOALS: 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 CC-486. 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.

Tracking Information