Clinical trial NCT00281840
Conditions: Head and Neck Cancer
Keywords: stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx
Sponsor: Case Comprehensive Cancer Center
Start date: 2005-09-01; Completion date: 2012-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. 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 bevacizumab together with docetaxel and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and radiation therapy works in treating patients with stage III or stage IV head and neck cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the time to progression in patients with stage III or IV squamous cell carcinoma of the head and neck treated with bevacizumab in combination with docetaxel and radiotherapy.

Secondary

* Compare the objective response rate, locoregional control rate, duration of response, patterns of failure, and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo radiotherapy once daily, 5 days a week, for 8 weeks and receive docetaxel IV over 1 hour once a week for 8 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year.

Approximately 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: bevacizumab intervention 2: docetaxel intervention 3: conventional surgery intervention 4: radiation therapy
Intervention descriptions: intervention 1: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity. intervention 2: docetaxel IV over 1 hour once a week for 8 weeks intervention 3: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection intervention 4: radiotherapy once daily, 5 days a week, for 8 weeks

Protocol documents: