NCT00133224终止3 期
A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain
Cell Genesys113 个研究点 分布在 3 个国家目标入组 408 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 408
- 试验地点
- 113
- 主要终点
- Survival
研究概览
简要总结
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
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
- •Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- •Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- •Detectable metastases
- •ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
- •Any Gleason score
- •Only one prior treatment with systemic chemotherapy
- •No prior treatment with gene therapy
- •No prior immunotherapy for prostate cancer
- •Taxane naïve
- •Experiencing cancer-related pain
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Immunotherapy allogeneic GM-CSF secreting cellular vaccine (Biological)
2
Other
干预措施: Chemotherapy (docetaxel and prednisone) (Drug)
结局指标
主要结局
Survival
时间窗: 0
次要结局
- Time to disease progression. Time to pain progression.(0)
研究者
研究点 (113)
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