A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 13
- 主要终点
- Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor cells less resistant to the drugs.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy, in terms of prostate-specific antigen response, of docetaxel and prednisone with or without OGX-011 in patients with hormone-refractory locally recurrent or metastatic prostate cancer.
Secondary
- Determine the objective response rate and duration in patients treated with these regimens.
- Determine the safety and toxic effects of these regimens in these patients.
- Determine the overall and progression-free survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Docetaxel plus prednisone
干预措施: prednisone (Drug)
OGX011, Docetaxel and Prednisone
干预措施: custirsen sodium (Drug)
OGX011, Docetaxel and Prednisone
干预措施: docetaxel (Drug)
OGX011, Docetaxel and Prednisone
干预措施: prednisone (Drug)
Docetaxel plus prednisone
干预措施: docetaxel (Drug)
结局指标
主要结局
Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study
时间窗: 2 years
次要结局
- Toxicity(2 years)
- Time to treatment failure(2 years)