23
Participants
Start Date
August 31, 2004
Primary Completion Date
March 31, 2009
Study Completion Date
September 30, 2011
erlotinib hydrochloride
Cohort (-1) = 50 mg daily Cohort 1 = 50mg daily Cohort 2= 75 mg daily Cohort 3 = 100mg daily Cohort 4 = 100mg daily Cohort 5 = 150mg daily
gemcitabine hydrochloride
Gemcitabine will be given at a dose of 100 mg/m2 for the first cohort and escalated to a fixed dose of 200 mg/m2 for the remaining 3 cohorts
oxaliplatin
Oxaliplatin will be given at 30 mg/m2 weekly for the first two cohorts and then will be dose-escalated to 45 mg/m2 and 60 mg/m2 for the next 2 in cohorts
radiation therapy
5040 cGy, every week, up to 6 weeks
gemcitabine hydrochloride
Given weekly at a starting dose of 100mg/m2 in the first 3 cohorts and dose escalated to 200 mg/m2 for the remaining 2 cohorts
Oxaliplatin
The Part II dose of oxaliplatin will be determined by Part I of the study. The dose for Part II will be one dose level increase from the MTD determined in Part I.
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill
National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER