Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	18 and over	Pharmaceutical / Industry	UPCC-6398 ALZA-98-023-ii, NCI-V99-1518, NCT00003777

Objectives

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

Mitchell Machtay, MD, Protocol chair(Contact information may not be current)		Ph: 215-662-2428 Email: machtay@xrt.upenn.edu

Registry Information
Official Title		A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma
Trial Start Date		1998-12-02
Registered in ClinicalTrials.gov		NCT00003777
Date Submitted to PDQ		1999-02-11
Information Last Verified		2002-11-01
NCI Grant/Contract Number		CA16520

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