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

NCT ID: NCT00243113

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-11-30

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 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.

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 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.

Conditions

Head and Neck Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aichi Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Nobukazu Fuwa

Role: STUDY_CHAIR

Aichi Cancer Center

Locations

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Hirosaki University, School of Medicine

Hirosaki, Aomori, Japan

Chiba University

Chiba, Chiba, Japan

Yokohama City University

Yokohama, Kanagawa, Japan

Shinshu University Health Center

Matsumoto, Nagano, Japan

Nara Medical University Cancer Center

Nara, Nara, Japan

Graduate School of Medical Science at the University of Ryukyu

Okinawa, Okinawa, Japan

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, Japan

National Hospital Organization - Medical Center of Kure

Hiroshima, , Japan

Countries

Japan

Other Identifiers

AICHI-UHA-HN04-02

Identifier Type: -

Identifier Source: secondary_id

CDR0000439499

Identifier Type: -

Identifier Source: org_study_id