Clinical Trials at Englewood Hospital: Oncology
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EHMC IRB Study #: E-13-479
Dr. Minaxi Jhawer
National Cancer Institute - SWOG
S1115: Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs mFOLFOX in Patients with Metastatic Pancreatic Cancer After Prior
Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma and must have received one line, and no more than one line, of prior
gemcitabine chemotherapy for pancreatic cancer.
To assess overall survival and assess progression free survival (PFS) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and
MK-2206 compared to those treated with mFOLFOX.
Summary of procedures:
Patients will be randomized to reduce bias into 2 treatment groups: 'Arm 1' will be a positive control ( mFOLFOX) or 'Arm 2' (a combination of 2 drugs AZD6244 Hydrogen Sulfate
plus MK-2206. All treatment regimens will be given in approximately 4 -week cycles (28 days) for a total of 4 cycles.
All patients will be assessed for disease progression during
treatment and then every 8 weeks until progression and then once every 6 months for 3 years from time of registration