Skip Navigation
 
 
 
 
 
Print This Page
Share this page: More
 

Search Results

Title:
J1220: A Phase I/II Pharmacodynamic Study of Hydroxychloroquine in Combination with Gemcitabine/Abraxane to Inhibit Autophagy in Pancreatic Cancer.
Protocol Number:
J1220
Phase:
Phase I/II
Physician:
Ana De jesus-acosta
Purpose:
Primary Objective Phase I To define the Phase II dose and to describe the dose-limiting toxicity of the combination of HCQ with gemcitabine/abraxane in previously untreated patients with advanced pancreatic cancer. Primary Objectives Phase II To describe the one year overall survival of the combination of HCQ with gemcitabine/abraxane in previously untreated patients with advanced pancreatic cancer.
Eligibility:
--Patients must have histologically or cytologically documented advanced or metastatic adenocarcinoma of the pancreas. ---Patients may have had prior adjuvant treatment for pancreatic cancer. The last dose of chemotherapy must have been greater than 4 months prior to study entry. --Patients with prior radiotherapy are acceptable. --Patients must have an accessible primary tumor or metastasis, and be willing to have a pre-treatment and post-treatment tumor biopsy (at 6 to 8 weeks after beginning). NOT ELIGIBLE: Patients with previous treatment with abraxane. Patients on therapeutic doses of Coumadin ( greater than 1 mg daily). The use of therapeutic or prophylactic low molecular weight heparin or fragmin is permitted.
Treatment:
Patients entering the Phase I portion of the trial will not be randomized. Patients entering the Phase II part of the trial will be randomized to receive HCQ Treatment Plan --Therapy will be administered as follows. All patients in the Phase I portion will receive HCQ daily. -- In the Phase II portion, patients will be randomly assigned to receive HCQ or not (no placebo, no blinding). Administration Abraxane 125mg/m2 IV infusion Day 1, 8, 15 Gemcitabine 1000mg/m2 IV infusion Day 1, 8, 15 Hydroxychloroquine 800 or 1200 mg/day PO daily (400mg or 600mg BID)Daily
Population:
Adult
Last Update
07/31/2014 04:02 AM
 

Read Our Blogs
Cancer Matters: timely topics
Our Cancer: for caregivers

 

Cancer Dictionary

NCI Dictionary of Cancer Terms, a resource with more than 6,000 terms related to cancer and medicine.

Traveling for care?

blue suitcase

Whether crossing the country or the globe, we make it easy to access world-class care at Johns Hopkins.

Maryland 410-955-5222
U.S. 410-955-5222
International +1-410-614-6424

NCI CCC

 
 
 
 
 

© The Johns Hopkins University, The Johns Hopkins Hospital, and Johns Hopkins Health System. All rights reserved.

Privacy Policy and Disclaimer