EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Amifostine; Carboplatin; Taxol; Radiotherapy
Intervention description: Amifostine will be given at dose of 500 mg IV within one hour before radiation; Carboplatin for 100 mg/m2 and will be administered after the taxol infusion; Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose; Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy
Intervention MeSH terms: Carboplatin; Amifostine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck cancer

Summary:

      Purpose of this study:

      There is some evidence that the best treatment for head and neck cancer involves a
      combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer
      treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses
      special medications. This study uses two chemotherapy drugs (Taxol and Carboplatin), which
      are FDA approved for treating head and neck cancers. This treatment combination has been
      associated with difficulty, pain, or a burning sensation upon swallowing (called
      esophagitis), and decrease in blood cells (cells in the blood which fight against infection).
      The purpose of this study is to investigate whether the addition of another drug, Amifostine,
      can reduce the side effects of current combination treatment (radiation and chemotherapy
      which is standard of care). The addition of Amifostine is the investigational part of the
      study. The research study is also looking at the side effects of Amifostine and cancer's
      growth response to this combination treatment.
    

Eligibility criteria:

        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.