Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy works in treating patients with stage II or stage III cancer of the larynx or hypopharynx.

Detailed Description
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OBJECTIVES: Primary Determine the objective response of the primary tumor in patients with stage II or III squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy. Secondary Determine the local relapse-free survival of patients treated with this regimen. Determine the larynx-preservation survival of patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Determine the protocol completion rate in patients treated with this regimen. Determine the adverse effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.

Official Title
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Multi-Institutional Phase II Study of Weekly Docetaxel and Concurrent Radiotherapy for Laryngeal and Hypopharyngeal Cancer in the Group of Elderly and/or Patients With Medical Illness

Conditions
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Head and Neck Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx Stage II or III disease Solitary lymph node metastasis located in level II-III allowed Age 70 and over OR meets 1 of the following criteria: Creatinine clearance 30-60 mL/min History of platinum allergy Diagnosis of unstable angina Ineligible for systemic chemotherapy, including high-dose platinum-containing regimens PATIENT CHARACTERISTICS: Age See Disease Characteristics Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC > 3,000/mm^3 Neutrophil count > 1,500/mm^3 Hemoglobin > 10 g/dL Platelet count > 100,000/mm^3 Hepatic AST and ALT ≤ 2.0 times upper limit of normal Bilirubin < 2.0 mg/dL No severe liver disease Renal See Disease Characteristics Creatinine clearance ≥ 30 mL/min No severe renal disease Pulmonary No severe pulmonary disease Other No severe neurologic disease PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior systemic chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery No prior surgery
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
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response of primary tumor |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local complete response rate |  |  | 
| Local progression-free survival at 2 years |  |  | 
| Local relapse-free survival |  |  | 
| Larynx preservation survival at 2 years |  |  | 
| Overall survival at 2 years |  |  | 
| Treatment completion rate |  |  | 
| Incidence of adverse effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx