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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243113
• Other study ID #: CDR0000439499
• Secondary ID: AICHI-UHA-HN04-0
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2005
• Last updated: March 25, 2013
• Start date: June 2004
• Est. completion date: November 2008

Study information

• Verified date: March 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• docetaxel

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Japan	Chiba University	Chiba City	Chiba
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka
Japan	Hirosaki University, School of Medicine	Hirosaki	Aomori
Japan	National Hospital Organization - Medical Center of Kure	Hiroshima
Japan	Shinshu University Health Center	Matsumoto	Nagano
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Nara Medical University Cancer Center	Nara
Japan	Graduate School of Medical Science at the University of Ryukyu	Okinawa
Japan	Yokohama City University	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Aichi Cancer Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response of primary tumor			No
Secondary	Local complete response rate			No
Secondary	Local progression-free survival at 2 years			No
Secondary	Local relapse-free survival			No
Secondary	Larynx preservation survival at 2 years			No
Secondary	Overall survival at 2 years			No
Secondary	Treatment completion rate			No
Secondary	Incidence of adverse effects			Yes