Status:
COMPLETED
Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
Lead Sponsor:
Aichi Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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...
Detailed 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 radiother...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00243113
Start Date
June 1 2004
End Date
November 1 2008
Last Update
March 26 2013
Active Locations (9)
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1
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
2
Hirosaki University, School of Medicine
Hirosaki, Aomori, Japan, 036-8562
3
Chiba University
Chiba, Chiba, Japan, 260-8677
4
Yokohama City University
Yokohama, Kanagawa, Japan, 236-0004