S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
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: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin
 and docetaxel works in treating patients with completely resected stage III or stage IV head
 and neck cancer.
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.
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

 -  Hemoglobin ≥ 8.0 g/dL

 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 known history of severe hypersensitiviy reaction to products containing Polysorbate
 80

 -  No other malignancy within the past 5 years except adequately treated basal cell or
 squamous cell skin cancer, carcinoma in situ 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