90
Participants
Start Date
August 31, 2009
Primary Completion Date
November 30, 2012
Study Completion Date
August 31, 2015
Imprime PGG Injection
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
Cetuximab
initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Paclitaxel
200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Medical College of Georgia, Augusta
Georg-August University Gottingen, Göttingen
HELIOS Klinikum Wuppertal, Medizinische Klinik 1, Wuppertal
Providence Medical Group, Terre Haute
University of Minnesota, Minneapolis
Mary Crowley Medical Research Center, Dallas
Allison Cancer Center, Midland
Universitätsklinikum Ulm, Ulm
Helios Clinic Emil von Behring, Berlin
Municipal Clinic Frankfurt Hoescht, Frankfurt
University Clinical Heidelberg, Heidelberg
Clinic Minden, Minden
Techincal University of Munich, Munich
Clinic Nurnberg Nord, Nuremberg
Lead Sponsor
HiberCell, Inc.
INDUSTRY