302
Participants
Start Date
May 31, 2013
Primary Completion Date
July 29, 2016
Study Completion Date
March 24, 2017
FOLFIRINOX
FOLFIRINOX consisting of Oxaliplatin 85 mg/m\^2 IV over 2 hours; Irinotecan 180 mg/m\^2 IV over 90 minutes; Leucovorin 400 mg/m\^2 IV over 2 hours; Fluorouracil 2.4 g/m\^2 IV over 46 hours
Algenpantucel-L Immunotherapy
Algenpantucel-L Immunotherapy (HAPa) consisting of 300 Million HAPa cells given by intradermal injection
5-FU Chemoradiation
5-FU Chemoradiation consisting of 5-FU continuous IV infusion of 200-250 mg/m\^2/day given 5-7 days each week over 5.5 weeks concurrently with external beam radiation
Gemcitabine
Gemcitabine 1000 mg/m\^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest.
Capecitabine
Capecitabine consisting of 825 mg/m\^2 PO BID M-F concurrently with external beam radiation
Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m\^2 given intravenously over 30-40 minutes
Mount Sinai Medical Center, New York
Thomas Jefferson University, Philadelphia
University of Virginia, Charlottesville
Wake Forest Baptist Health, Winston-Salem
University of Florida, Gainesville
University of Miami, Miami
Boca Raton Regional Hospital, Boca Raton
USF Tampa General, Tampa
H. Lee Moffitt Cancer Center, Tampa
University of Tennessee Medical Center, Knoxville
University of Louisville, Louisville
The Ohio State University, Columbus
Indiana University, Indianapolis
Indiana University Health Goshen Center for Cancer Care, Goshen
Beaumont CCOP, Royal Oak
University of Wisconsin, Madison
Vince Lombardi Cancer Center, Green Bay
Illinois Cancer Specialists, Arlington Heights
University of Kansas Cancer Center, Westwood
University of Oklahoma, Oklahoma City
University of Texas Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
Arizona Cancer Center, Tucson
Renown Regional Medical Center, Reno
Cedars-Sinai Medical Center, Los Angeles
California Pacific Medical Center, San Francisco
Sutter Institute for Medical Research, Sacramento
Oregon Health and Science University, Portland
University of Washington - Seattle Cancer Center Alliance, Seattle
Stamford Hospital, Stamford
Virginia Piper Cancer Institute, Minneapolis
Jersey Shore University Medical Center, Neptune City
Lead Sponsor
NewLink Genetics Corporation
INDUSTRY