S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Study Overview
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Brief Summary
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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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.

Detailed Description
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OBJECTIVES: Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated fractionation/concomitant boost radiotherapy and cisplatin. Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy. Determine the overall complete response rate (confirmed and unconfirmed) in patients treated with this regimen. Determine the toxic effects of this regimen in these patients. OUTLINE: Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity. Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course of induction chemotherapy, patients receive accelerated fractionation radiotherapy once daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5 days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22. Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Official Title
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Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer

Conditions
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Head and Neck Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck (excluding lip, nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate of the primary lesion or neck mass Stage III or IV disease No evidence of distant metastases Negative chest x-ray Primary site in the head and neck region must be identified No unknown primary site Considered to be appropriate for definitive radiotherapy with curative intent PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Granulocyte count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN ALT or AST less than 1.5 times ULN Renal Creatinine less than 1.5 mg/dL Cardiovascular No myocardial infarction within the past 3 months No unstable or uncontrolled angina Other Not pregnant or nursing Fertile patients must use effective contraception No other prior 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 No evidence of pre-existing peripheral neuropathy No active systemic infection No history of hypersensitivity reaction to products containing polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior radiotherapy Surgery No prior surgery for head or neck cancer

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: docetaxel|nan|
|Drug: fluorouracil|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 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 hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the oropharynx