RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

Condition	Treatment or Intervention	Phase
Oral Cancer Throat Cancer Nose Cancer	Procedure: supportive care  Procedure: chemotherapy  Procedure: surgery  Procedure: radiation therapy  Procedure: radioprotection  Behavior: supportive care/therapy  Drug: chemoprotection  Drug: amifostine  Drug: cisplatin  Drug: fluorouracil	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer. II. Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients.

PROTOCOL OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32. Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field
• Pathologic stage of recurrence must be rT3-4 and/or rN2-3
• The following sites are eligible: Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+; Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+; Any site: Positive margin(s), at least 2 nodes or ECS
• No primary tumor of the nasopharynx
• Must be eligible for or have undergone complete resection which leaves behind no gross residual disease
• Must have prior head and neck irradiation of 45-75 Gy
• Lifetime spinal cord radiotherapy dose no greater than 50 Gy
• No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)
• No active acute radiation mucositis from previous radiotherapy

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy)
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 6 months since prior radiotherapy; Prior radiotherapy treatment records must be available
• Surgery: No prior salvage surgery consisting of partial laryngectomy

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: WBC at least 4,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed); Platelet count at least 100,000/mm3
• Hepatic: SGOT or SGPT no greater than 3 times upper limit of normal; Bilirubin no greater than 2 mg/dL
• Renal: Creatinine no greater than 1.5 mg/dL
• Cardiovascular: No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months; No severe cerebrovascular disease or hypotension not caused by antihypertensive medication
• Other: Not pregnant; Fertile patients must use effective contraception; No allergy to cisplatin, fluorouracil, or amifostine; No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing

Pennsylvania
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States

Study chairs or principal investigators

Mitchell Machtay,  Study Chair,  University of Pennsylvania Cancer Center   

Study ID Numbers:  CDR0000066906; UPCC-6398; NCI-V99-1518; ALZA-98-023-ii
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003777
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08