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

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

The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with 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