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Completed

NCT Number: NCT00243113

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

radiation therapy

Radiation

Primary outcomes

  1. Objective response of primary tumor

Secondary outcomes

  1. Local complete response rate

  2. Local progression-free survival at 2 years

  3. Local relapse-free survival

  4. Larynx preservation survival at 2 years

  5. Overall survival at 2 years

  6. Treatment completion rate

  7. Incidence of adverse effects

Sponsors and collaborators

Lead sponsor

Aichi Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 21, 2005
Registry last updated
Mar 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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