Clinical trial NCT00243113: Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-10-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Objective response of primary tumor
Secondary outcomes:
measure: Local complete response rate
measure: Local progression-free survival at 2 years
measure: Local relapse-free survival
measure: Larynx preservation survival at 2 years
measure: Overall survival at 2 years
measure: Treatment completion rate
measure: Incidence of adverse effects
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University, School of Medicine
state: Aomori
city: Chiba City
country: Japan
facility: Chiba University
state: Chiba
city: Yokohama
country: Japan
facility: Yokohama City University
state: Kanagawa
city: Matsumoto
country: Japan
facility: Shinshu University Health Center
state: Nagano
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
city: Hiroshima
country: Japan
facility: National Hospital Organization - Medical Center of Kure
city: Nara
country: Japan
facility: Nara Medical University Cancer Center
city: Okinawa
country: Japan
facility: Graduate School of Medical Science at the University of Ryukyu
Study officials:
affiliation: Aichi Cancer Center
name: Nobukazu Fuwa
role: STUDY_CHAIR
References: