Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

August 31, 2016

Conditions
Head and Neck Cancer
Interventions
OTHER

bevacizumab, cisplatin, cetuximab, radiation therapy

Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions. A total dose of 70Gy is planned for the primary tumor site over approximately 33 treatment days. Day 1 will refer to the first day of radiation therapy. Concurrent with radiation therapy, patients will receive cisplatin (50 mg/m2 IV on Days 1, 2 and 22, 23) and bevacizumab (15 mg/kg IV on Days 1 and 22). Cetuximab will be administered according to the Bonner regimen (4),with a loading dose approximately 7 days prior to the start of radiation therapy (400 mg/m2 IV once, on approximately Day minus 7), followed by weekly cetuximab infusions (250 mg/m2 IV weekly X 7 infusions) until the completion of radiation therapy.

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

10591

Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow

11570

Memorial Sloan Kettering Cancer Center at Mercy Medical Center, Rockville Centre

11725

Memorial Sloan Kettering Cancer Center at Commack, Commack

07939

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER