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Phase II Study of Docetaxel and Radiotherapy in Patients With Stage II or III Squamous Cell Carcinoma of the Larynx or Hypopharynx

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed Not specified Other AICHI-UHA-HN04-02
NCT00243113

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

No prior systemic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

No prior surgery

Patient Characteristics:

Age

See Disease Characteristics

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

WBC > 3,000/mm³
Neutrophil count > 1,500/mm³
Hemoglobin > 10 g/dL
Platelet count > 100,000/mm³

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

Expected Enrollment

A total of 25-50 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Objective response of primary tumor

Secondary Outcome(s)

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

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.

Trial Contact Information

Trial Lead Organizations

Aichi Cancer Center

Nobukazu Fuwa, Protocol chair
Ph: 81-52-762-6111

Registry Information

Official Title		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

Trial Start Date		2004-06-01

Trial Completion Date		2008-03-31

Registered in ClinicalTrials.gov		NCT00243113

Date Submitted to PDQ		2005-06-28

Information Last Verified		2008-03-30

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.