ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

November 4, 2015

Study Completion Date

February 14, 2017

Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

Cetuximab

Pre-Surgery: IV, 400 mg/m2 day 1 then 250 mg/m2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT

PROCEDURE

Surgery

Surgery for tumor

RADIATION

Post-surgical radiation

Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery

DRUG

Cisplatin or carboplatin

Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy

Trial Locations (1)

15232

UPCI - Hillman Cancer Center, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Robert Ferris

OTHER