Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
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. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin and bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Bevacizumab may also make tumor cells more sensitive to radiation therapy. Giving bevacizumab together with hormone therapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with hormone therapy and radiation therapy works in treating patients with high-risk locally advanced prostate cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •High-risk, locally advanced disease (T2b-T4 disease), meeting 1 of the following criteria:
- •Gleason score 8-10
- •Prostate-specific antigen > 20 ng/dL AND Gleason score 7
- •T2a disease allowed provided ≥ 5 biopsies contain Gleason score 4 +3 cancer (minimum of 10 biopsies total required)
- •No evidence of metastatic disease within the past 60 days by physical examination, chest x-ray, bone scan, and CT scan of abdomen and pelvis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Hemoglobin > 8 g/dL
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •Blood pressure ≤ 150/100 mm Hg
- •No cardiovascular disease, including any of the following:
- •Unstable angina
- •New York Heart Association class II-IV congestive heart failure
- •History of myocardial infarction within the past 6 months
- •History of stroke within the past 6 months
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks since prior major surgery
- •No prior hormonal therapy (except finasteride for obstructive voiding symptoms) for prostate cancer
- •No prior or concurrent chemotherapy, biologic therapy, or radiotherapy for prostate cancer
排除标准
- 未提供
结局指标
主要结局
Safety
Efficacy
次要结局
未报告次要终点