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