Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

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