S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: docetaxel
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemoRT after surgery<br>chemoRT with cisplatin and docetaxel after surgery | Drug: cisplatin<br>* 75 mg/m2 IV, Day 1, q 21 days for 3 cycles<br>* Other names: platinol;Drug: docetaxel<br>* 15 mg/m2 IV, Day 1, 1 7 days for 6 doses<br>* Other names: taxotere;Radiation: radiation therapy<br>* 200 cGy/day, Days 1-5, q week for 6 weeks<br>* Other names: RT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression |  |  | 
| Disease-free survival |  |  | 
| Symptomatic deterioration |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III salivary gland cancer, stage IV salivary gland cancer, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, salivary gland squamous cell carcinoma