EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)

Inclusion Criteria:

1. Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites. The following TNM stages by sites will be eligible.

   Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses: T4 N0-3, A,B,C T3 N1-3 A,B,C any T, N3 A,B,C Unknown primary: Tx, N3 A,B,C Note: Only clearly unresectable T4 N0 lesions are eligible for study provided the reasons for unresectability are due to extensive anatomic involvement and are outlined by the surgeon.
2. Karnofsky performance status of 70% or better at screen and on first day of treatment.
3. Patients with loco-regional recurrences from any site with no prior radiation therapy and not amenable for salvage surgery are eligible for study.
4. No evidence of distant metastatic disease.
5. No previous radiation therapy
6. No previous chemotherapy.
7. Adequate renal \& bone marrow function determined by the following laboratory parameters.

   WBC 3500/ul or higher Platelet count 100.000/ul or higher Hemoglobin 9.0 g/dl or higher BUN 25 mg/dl or less, and Screatinine 2.0 mg/dl or less Total bilirubin less than 2.0 mg/dl, AST/ALT less than 3 times the ULN Creatinine Clearance 50 cc/min or higher
8. Evidence of measurable disease.
9. No evidence of concomitant malignancy except for non-melanomatous skin cancer (controlled or controllable) or carcinoma in situ of the cervix.
10. Signed informed consent.
11. No concomitant life threatening or uncontrolled serious medical illness such as end stage congestive heart failure cardiac arrythmia, liver disease and organic brain syndrome.
12. Age 18 years or older.

Exclusion Criteria:

1. Preexisting clinically significant neuropathy.
2. Patients currently taking antiarrhythmic medications are excluded.
3. History of poorly-controlled hypertension, angina, arrhythmias, or a history within the past 6 months of myocardial infarction or acute congestive heart failure.
4. Requirement for concurrent use of pilocarpine.
5. Treatment with any investigational drugs within 4 weeks of study entry.
6. Pregnant or lactating females or females of child bearing potential not employing adequate contraception.