Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer

Inclusion Criteria

• •Patients must have a Karnofsky Performance Index ≥60%
• •Patients must be over the age of 18.
• •Patients must have a life expectancy of at least 6 months.
• •Women of childbearing age must have a negative serum pregnancy test and agree to use an effective method of contraceptive.
• •Patients with a cardiac history should be cleared with a medical internist. In general, patients with a history of prior bradyarrythmias, atrioventricular (AV) conduction defects or marginal cardiac function will be eligible.
• •Patients must have resectable stage III, stage IVA, stage IVB (without distant metastases) squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. Hypopharyngeal carcinomas may also be stage II.
• •Patients must not have had prior chemotherapy or radiotherapy (to the primary site or nodes).
• •Patients may not be planning to receive while on study concomitant immunotherapy or hormonal therapy, except oral contraceptives or hormone replacement therapy.
• •Patients must have adequate hepatic function documented by a normal serum bilirubin 0- 1.5mg/L and serum transaminases \< 4 x upper limit.
• •Patients must have adequate renal function documented by a serum creatinine not above upper institutional normal limits and/or 24 hour OR calculated creatinine clearance \>60 ml/min. using the following formula:
• •(140-age) x Wt (kg) x .85 (if Estimated Creatinine Clearance = 72 x Creatinine (mg/dl) female)
• •Patients must have adequate bone marrow function documented by platelet count ≥ 100,000 and absolute neutrophil count ≥ 2,000.
• •Patients will have surgery according to Section 5.3. Operative and pathology reports must be sufficiently detailed to confirm that surgery was done according to the guidelines.
• •Patients must be examined by a multi-modality team (consisting of a head and neck surgeon, medical oncologist, and radiation oncologist) prior to entry on study.
• •All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.