Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine
Status:
Completed
Trial end date:
2018-02-28
Target enrollment:
Participant gender:
Summary
This is a randomized phase II trial that will examine the ability of the hydroxychloroquine
to improve the clinical activity of a pre-operative regimen of gemcitabine and nab-paclitaxel
in subjects with potentially resectable adenocarcinoma of the pancreas. Eligible subjects
will receive 2 cycles of gemcitabine and nab-paclitaxel (day 1, 8, 15) with or without
hydrocychloroquine followed by surgical resection. Primary endpoint will be histologic
response as graded by Evans criteria. Secondary endpoints will be CA19-9 response and PET
response. Pre and post treatment tissue biopsies will be obtained to assess for levels of
autophagy in tumor, liver and peripheral blood.