NCT00193232已完成2 期
A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- objective response rate
研究概览
简要总结
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.
详细描述
Upon determination of eligibility, patients will be receive:
- Docetaxel + Bortezomib
Patients with objective responses or stable disease will continue treatment for eight courses or until disease progression is documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Prostate cancer, and objective evidence of metastatic disease
- •Progression while receiving androgen ablation therapy
- •No previous chemotherapy
- •Measurable or evaluable disease in conjunction with elevated serum PSA levels
- •ECOG performance status 0, 1, or 2
- •Adequate bone marrow, liver and kidney function
- •Voluntarily provide written informed consent
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Moderate or severe peripheral neuropathy
- •Age < 18 years
- •Other serious medical conditions that may interfere with protocol therapy
- •Other active malignancies
- •history of treatment for other invasive cancers within 3 years
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
objective response rate
次要结局
- progression-free survival
- overall survival
研究者
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