128
Participants
Start Date
July 9, 2010
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Paclitaxel
135 mg/m\^2 weekly, Weeks 1 - 6
Carboplatin
AUC of 2 weekly, Weeks 1 - 6
Cetuximab
"PCC Arm: 400 mg/m\^2 by vein over about 1-2 hours on Day 1; 250 mg/m\^2 weeks 2 - 6.~C-TPF Arm: 250 mg/m2 weeks 2, 4, 5, 7 and 8."
Docetaxel
75 mg/m\^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Cisplatin
100 mg/m\^2 by vein over 1-3 hours on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Fluorouracil
700 mg/m\^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Radiotherapy (RT)
Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.
Chemotherapy
PCC group receives 6 and C-TPF group receives 3 chemotherapy treatment cycles. If receiving radiation + chemotherapy, weekly Cisplatin 40 mg/m\^2 by vein over 1-3 hours or Carboplatin AUC 2 by vein over 1 hour beginning 2 to 3 weeks after conclusion of induction program.
Dana Farber Cancer Institute, Boston
University of Texas MD Anderson Cancer Center, Houston
Dana-Farber Cancer Institute
OTHER
M.D. Anderson Cancer Center
OTHER