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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: docetaxel; Radiation: radiation therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan, 737-0023
    • National Hospital Organization - Medical Center of Kure
  • Nara, Japan, 634-8522
    • Nara Medical University Cancer Center
  • Okinawa, Japan, 903-0215
    • Graduate School of Medical Science at the University of Ryukyu
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8562
      • Hirosaki University, School of Medicine
  • Chiba
    • Chiba City, Chiba, Japan, 260-8677
      • Chiba University
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Shinshu University Health Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-31
      • Hamamatsu University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response of primary tumor

Secondary Outcome Measures

Outcome Measure
Local relapse-free survival
Overall survival at 2 years
Local complete response rate
Local progression-free survival at 2 years
Larynx preservation survival at 2 years
Treatment completion rate
Incidence of adverse effects

Collaborators and Investigators

• Sponsor: Aichi Cancer Center
• Investigators: Study Chair: Nobukazu Fuwa, Aichi Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: October 20, 2005
• First Submitted That Met QC Criteria: October 20, 2005
• First Posted (Estimate): October 21, 2005

Study Record Updates

• Last Update Posted (Estimate): March 26, 2013
• Last Update Submitted That Met QC Criteria: March 25, 2013
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CDR0000439499; AICHI-UHA-HN04-02