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

Aichi Cancer Center50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

docetaxelDRUG

radiation therapyRADIATION

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (9)

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Hirosaki University, School of Medicine

Hirosaki, Aomori, Japan

Chiba University

Chiba, Chiba, Japan

Yokohama City University

Outcomes

Primary Outcomes

Objective response of primary tumor

Secondary Outcomes

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

Data from ClinicalTrials.gov

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