Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer

• Status: Completed
• Trial end date: 1996-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy and chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy and amifostine in treating patients who have stage II, stage III, or stage IV head and neck cancer that cannot be surgically removed.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Albumin-Bound Paclitaxel; Amifostine; Cisplatin; Fluorouracil; Paclitaxel

Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck, including: Stage III or IV: oral cavity, paranasal sinus, hypopharynx, oropharynx, larynx, and nasopharynx OR Unknown primary carcinoma of the head and neck with greater than N1 disease if no planned neck dissection Evaluable disease No metastases below clavicle by clinical or radiographic diagnosis All hypopharynx and nasopharynx patients with N3 disease undergo a CT scan of the chest

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 130,000/mm3 WBC at least 3,400/mm3 Hemoglobin greater than 10.0 g/dL (transfusion allowed) Hepatic: Not specified Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No active heart disease No myocardial infarction within past 6 months No uncontrolled congestive heart failure No uncontrolled angina Cardiac ejection fraction at least 50% by MUGA scan for patients under 65 without antecedent heart disease, at least 55% for patients over 65 and/or with antecedent heart disease Pulmonary: FEV greater than 60% of predicted Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the treatment field Surgery: Eligible for PEG gastrostomy Other: At least 24 hours since prior antihypertensive and diuretic medications (prior to amifostine and chemotherapy regimens)