A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
- 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
- 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
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
Time to progression
The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained. The probability of disease progression free survival will be estimated by Kaplan-Meier method (39) and 3-year disease progression free survival rate will be then obtained and compared with those in the literature.
3 yrs after treatment
Panayiotis Savvides, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Southwest General Health Center||Middleburgh Heights, Ohio 44130|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|
|UHHS Westlake Medical Center||Westlaker, Ohio 44145|