Phase I study of epidermal growth factor receptor (EGFR) inhibitor, erlotinib, and vascular endothelial growth factor monoclonal antibody, bevacizumab, in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)

5539 Background: Studies of EGFR inhibitors in SCCHN have demonstrated reproducible activity. Preclinical studies have implicated angiogenesis as a mechanism of resistance to these agents. Furthermore, angiogenesis has been linked with tumor progression and worse outcome in SCCHN. This phase I multi-institutional trial was undertaken to assess the feasibility and toxicity of adding bevacizumab, an anti-VEGF monoclonal antibody to erlotinib, an EGFR tyrosine kinase inhibitor. Methods: Eligible patients were required to have performance status 2 or better, measurable disease, intact organ function, no more than one prior therapy for recurrent/metastatic disease, and no prior EGFR or VEGF based therapy. Escalating doses of bevacizumab (5, 10, and 15 mg/kg IV q3 weeks) were administered with a fixed dose of erlotinib (150 mg PO QD) to consecutive patient cohorts to establish a phase II dose. Plasma VEGF and serum TGF-alpha levels were drawn prior to therapy, after 2 weeks, and after 8 weeks of therapy. Result...