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
N/A
N/A
Both
Head and Neck Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response of primary tumor
Safety Issue:
No
Principal Investigator
Nobukazu Fuwa
Investigator Role:
Study Chair
Investigator Affiliation:
Aichi Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000439499
NCT ID:
NCT00243113
Start Date:
June 2004
Completion Date:
November 2008
Related Keywords:
- Head and Neck Cancer
- 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
- Laryngeal Neoplasms
- Head and Neck Neoplasms
- Hypopharyngeal Neoplasms
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