Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria: * At least 18 years of age * Each patient must sign a study-specific informed consent form * Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI * Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin * Karnofsky Performance Status score of at least 60% * Primary tumor at least 4 cm in diameter Exclusion Criteria: Laboratory Values of: * Serum creatinine \> 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min * Serum total bilirubin \> 1.5 times the upper limit of normal * ALT (formerly SGPT) \> 1.5 times the upper limit of normal * Alkaline phosphatase \> 1.5 times the upper limit of normal * Absolute neutrophil count (ANC) \< 1500/L * Platelet count \< 100,000/L * 3+ or greater proteinuria on urinalysis and * Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx * Distant metastases * Prior history of cancer at any site treated with radiotherapy and/or chemotherapy * History of SCCHN diagnosed within 5 years of current diagnosis