A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

Inclusion Criteria: * Histologically confirmed diagnosis of squamous cell carcinoma of head and neck (SCCHN) * Recurrent or metastatic SCCHN, not amenable to local therapy * At least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy) * No more than 1 prior systemic therapy, given as part of multimodal treatment for locally advanced disease; * No prior systemic therapy for metastatic disease * Radiation therapy must be completed at least 4 weeks before study enrollment. * For palliative therapy, prior radiation therapy allowed to \<25% of the bone marrow (Cristy and Eckerman 1987), and prior radiation to the whole pelvis is not allowed. * Surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks before study enrollment. * An estimated life expectancy of at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Oken et al. 1982). * Biological tissue available for biomarker analysis on tumor tissue. * Disease status may be measurable or nonmeasurable as defined by Response Evaluation Criteria in Solid Tumors * Patient compliance and geographic proximity that allow for adequate follow-up. * Adequate organ function * Willingness to comply with Contraceptive Regimen * For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen \[for example, intrauterine device (IUD), birth control pills, or barrier device\] during and for 6 months…