Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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