Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor: David M. Brizel, MD
Study ID: NCT00140556
Phase: EARLY_PHASE1
Status: Completed

Conditions

Head and Neck Cancer
Pharynx Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Chemoradiotherapy — RADIATION
External beam radiation daily (M-F)
Cisplatin — DRUG
Cisplatin week 1 and 5 of radiation
Bevacizumab — DRUG
Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation
Erlotinib — DRUG
Erlotinib daily during radiation

Study Details

Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly and increases the risk of treatment failure. The addition of EGFR blockade to RT alone increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer. This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will be determined.