Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

June 30, 2011

Study Completion Date

May 31, 2012

Conditions
Cancer of Head and Neck
Interventions
DRUG

Erbitux, Paclitaxel & Carboplatin

"Paclitaxel, 40 mg/m2/week,~1-hour infusion (weeks 2-9.Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose.~Cetuximab: 400 mg/m2 IV (initial dose) week 1 then 250 mg/m2 IV weekly for 8 weeks weeks 2-9). Cetuximab will be administered 400mg/m2 IV on Day 1, then the first 250 mg/m2 IV dose will be given on day 8 (week 2) prior to carboplatin dose.~Carboplatin, AUC=2/week as a 30 minute infusion after cetuximab infusion (weeks 2-9)Carboplatin will be administered at a dose of AUC = 2/week IV bolus each week and will be administered prior to head and neck irradiation dose. (Carboplatin: AUC=2/week x 8 weeks (weeks 2-9)"

RADIATION

Radiation

XRT=Radiotherapy 1.8 Gy radiation/day, 5 days a week for a total of 70.2 Gy.(weeks 2-9) - IMRT is allowed

Trial Locations (1)

21201

University of Maryland & Baltimore VA medical centre, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

University of Maryland, Baltimore

OTHER