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

Aichi Cancer Center

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Radiation: radiation therapy; Drug: docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00243113

AICHI-UHA-HN04-02

CDR0000439499

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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