RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in 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. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells.

PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy using cisplatin and docetaxel in treating patients who have completely resected stage III or stage IV squamous cell carcinoma (cancer) of the head and neck.

Condition	Treatment or Intervention	Phase
Hypopharyngeal Cancer Laryngeal Cancer lip and oral cavity cancer Oropharyngeal Cancer paranasal sinus and nasal cavity cancer Salivary Gland Cancer	Drug: cisplatin  Drug: docetaxel  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: radiosensitization	Phase II

OBJECTIVES:

• Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin.
• Determine the toxicity of this regimen in these patients.
• Categorize the site(s) of disease relapse in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of squamous cell carcinoma of the head and neck
• Selected stage III or IV (no distant metastasis) disease
• The following TNM stages are excluded:
• T3, N0, M0
• T4a, N0, M0
• T4b, N3, M0
• Any T, any N, M1
• Complete total resection within the past 56 days AND has one or more of the following risk factors:
• Multiple pathologically confirmed lymph node metastases
• One or more lymph nodes with extracapsular extension of tumor
• Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection
• No primary nasopharyngeal carcinoma

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 mg/dL OR
• Creatinine clearance ≥ 60 mL/min

Other

• No pre-existing peripheral neuropathy
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix, or adequately treated stage I or II cancer currently in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for the malignancy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for the malignancy

Surgery

• See Disease Characteristics

Other

• No concurrent amifostine

Study chairs or principal investigators

Prakash C. Neupane, MD,  Cancer Care Central Missouri   
Harold E. Kim, MD,  Barbara Ann Karmanos Cancer Institute   
Stephen K. Williamson, MD,  University of Kansas   
George H. Yoo, MD,  Barbara Ann Karmanos Cancer Institute   

Study ID Numbers:  CDR0000365311; SWOG-S0217
Record last reviewed:  September 2004
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084435
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-09