Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

August 31, 2012

Study Completion Date

November 30, 2012

Conditions
Head and Neck Cancer
Interventions
DRUG

Cetuximab

250mg/m2(day 1, weekly x 10);

DRUG

5-FU

600 mg/m2/day; days 0-5 (120 h total) every other week x 5

DRUG

Hydroxyurea

500 mg PO BID, days 0-5 every other week x 5

RADIATION

Twice-daily radiation

150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)

DRUG

Cisplatin

100 mg/m2, week 1 and 4 on day 1 (or 2)

RADIATION

Accelerated fraction radiotherapy with concomitant boost

72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.

Trial Locations (1)

60637

University of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

University of Chicago

OTHER