Start Date
December 8, 2011
Primary Completion Date
December 31, 2016
Study Completion Date
December 31, 2016
Temsirolimus
All patients will receive temsirolimus. The dose of temsirolimus in this study will range from 15-25 mg depending on the dose level. Temsirolimus will be infused over a 30-60 minute period once a week for the duration of radiation therapy.
Cetuximab
"All patients will receive cetuximab. An initial loading dose of cetuximab 400 mg/m2, intravenously over 120 minutes at least 4 days before radiation therapy but no more than 7 days before the start of radiation therapy.~Thereafter, cetuximab will be infused at 250 mg/m2 dose over 60 minutes weekly for the duration of radiation therapy."
Cisplatin
All patients in Cohort A will receive cisplatin. The dose will be 20 mg/m2 or 30 mg/m2 depending upon the dose level.
Radiation Therapy
Patients will be treated on a linear accelerator fitted with multi-leaf collimators with 1.6-2.3 Gy fractions delivered daily 5 days per week over 4-7 weeks to a cumulative dose of 66 Gy. A variance of +/- 10% in this nominal prescription dose is allowable and will depend on the extent of residual disease, at the discretion of the attending radiation oncologist.
Collaborators (1)
Pfizer
INDUSTRY
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER