Trials / Completed
CompletedNCT01978184
Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Nathan Bahary, MD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gemcitabine | |
| DRUG | abraxane | |
| DRUG | hydroxychloroquine |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2018-02-06
- Completion
- 2018-02-28
- First posted
- 2013-11-07
- Last updated
- 2019-03-27
- Results posted
- 2019-03-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01978184. Inclusion in this directory is not an endorsement.