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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00243113
First received: October 20, 2005
Last updated: March 25, 2013
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: docetaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response of primary tumor [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local complete response rate [ Designated as safety issue: No ]
  • Local progression-free survival at 2 years [ Designated as safety issue: No ]
  • Local relapse-free survival [ Designated as safety issue: No ]
  • Larynx preservation survival at 2 years [ Designated as safety issue: No ]
  • Overall survival at 2 years [ Designated as safety issue: No ]
  • Treatment completion rate [ Designated as safety issue: No ]
  • Incidence of adverse effects [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2004
Study Completion Date: November 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243113

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00243113     History of Changes
Other Study ID Numbers: CDR0000439499, AICHI-UHA-HN04-02
Study First Received: October 20, 2005
Last Updated: March 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Laryngeal Neoplasms
Head and Neck Neoplasms
Hypopharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014