J1220: A Phase I/II Pharmacodynamic Study of Hydroxychloroquine in Combination with Gemcitabine/Abraxane to Inhibit Autophagy in Pancreatic Cancer.
Ana De jesus-acosta
Johns Hopkins Kimmel Cancer Center in Baltimore
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.
--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.
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
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