9
Participants
Start Date
October 31, 2005
Primary Completion Date
August 31, 2007
Study Completion Date
October 31, 2007
cetuximab
400mg/m2 initial dose week 1; followed by 250mg/m2/weekly starting week 2 with gemcitabine at fixed dose rate (10 mg/m2/min) + XRT. Cetuximab will start 1 week prior to all other treatment.
gemcitabine hydrochloride
"Dose Level Gemcitabine dose Gemcitabine infusion~-1 150mg/m2 15 Minutes 0 200mg/m2 20 minutes~1. 300mg/m2 30 minutes~2. 400mg/m2 40 minutes"
radiation therapy
"50.4 Gy, 28 fractions, 5.5 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to encompass gross disease with a margin of 1-1.5 cm.~The prescription point will be designated at the intersection of the multiple beams.~There are no planned interruptions \> 3 days."
Vanderbilt-Ingram Cancer Center, Nashville
National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER