Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer

Inclusion Criteria:

- Previously untreated squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx, or larynx.

- Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease).

- ECOG performance status less than or equal to 2.

- Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X
10^9/L, and hemoglobin > 9g/dL.

- Serum bilirubin < 1.25 times ULN and AST/ALT < 2.5 times ULN.

- Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.

Exclusion Criteria:

- Metastatic Disease

- Primary cancers of the nasal and paranasal cavities and of the nasopharynx

- Significant intercurrent illness that will interfere with the Chemotherapy or
Radiation Therapy during the trial

- Symptomatic peripheral neuropathy > grade 2

- Clinically significant hearing impairment

- Significant cardiac disease