Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

April 8, 2005

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2016

Conditions
Head and Neck Cancer
Interventions
BIOLOGICAL

cetuximab C225

400 mg/m\^2 IV over 120 minutes on Day 1, 250 mg/m\^2 IV over 60 minutes on Day 8, then weekly

DRUG

cisplatin

75 mg/m\^2 IV over 30-60 minutes starting day 15 every 3 weeks \* 3 (Days 1, 22, and 43 of radiation therapy (RT))

RADIATION

radiation therapy

RT 70 Gy / 35 starting Day 15, 200cGy / d \* 7 weeks (35 fractions)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Eastern Cooperative Oncology Group

NETWORK

NCT00096174 - Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck | Biotech Hunter | Biotech Hunter