Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer

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

The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.

Inclusion Criteria:

• Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
• Stage III or IV disease (excluding T1N1, and T2N1).
• 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