Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer
OBJECTIVES:
- Determine the safety and efficacy of giving bevacizumab together with hormonal therapy
and radiotherapy in patients with high-risk locally advanced prostate cancer.
OUTLINE: This is an open-label, pilot study.
Beginning in week 1, patients receive goserelin subcutaneously once every 3 months for 2
years. Patients also receive oral bicalutamide once daily and bevacizumab IV over 30- to
90-minutes once every 2 weeks in weeks 1-16 and undergo radiotherapy 5 days a week in weeks
9-16. After completion of radiotherapy, patients receive a higher dose of bevacizumab once
every 3 weeks in weeks 17-28.
After completion of study treatment, patients are evaluated at 30 days.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Safety
Yes
Jacqueline Vuky, MD
Study Chair
Virginia Mason Hospital/Medical Center
United States: Food and Drug Administration
CDR0000480370
NCT00348998
April 2006
Name | Location |
---|---|
Benaroya Research Institute at Virginia Mason Medical Center | Seattle, Washington 98101 |