A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone 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
- 185
- 试验地点
- 12
- 主要终点
- Antitumor response based on PSA decrease
研究概览
简要总结
The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.
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 —（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
1: 8 mg/m2 study drug + prednisone
Patupilone 8 mg/m2 + prednisone 5 mg bid daily
干预措施: Patupilone (Drug)
1: 8 mg/m2 study drug + prednisone
Patupilone 8 mg/m2 + prednisone 5 mg bid daily
干预措施: prednisone (Drug)
2: study drug + prednisone days 1 -8
Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid
干预措施: Patupilone (Drug)
2: study drug + prednisone days 1 -8
Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid
干预措施: prednisone (Drug)
3: Study drug + prednisone days 1 - 4
Patupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid
干预措施: Patupilone (Drug)
3: Study drug + prednisone days 1 - 4
Patupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid
干预措施: prednisone (Drug)
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily
Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
干预措施: prednisone (Drug)
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily
Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
干预措施: docetaxel (Drug)
结局指标
主要结局
Antitumor response based on PSA decrease
时间窗: Every 3 weeks
次要结局
- Measurable soft tissue response for both regimens(Every 6 weeks or every 12 weeks if patient has bone disease for bone scan)