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临床试验/NCT00089856
NCT00089856终止3 期

A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

Cell Genesys125 个研究点 分布在 1 个国家目标入组 626 人开始时间: 2004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
626
试验地点
125
主要终点
Survival

研究概览

简要总结

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

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

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
  • Any Gleason score
  • ECOG performance status 0-2

排除标准

  • Prior treatment with chemotherapy
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  • Significant cancer related pain

研究组 & 干预措施

2

Other

Standard of care - chemotherapy

干预措施: Chemotherapy (Taxotere and prednisone) (Drug)

1

Experimental

Immunotherapy

干预措施: Immunotherapy with allogeneic prostate vaccine (Biological)

结局指标

主要结局

Survival

时间窗: 0

次要结局

  • Bone pain and bone related events(0)

研究者

发起方
Cell Genesys
申办方类型
Industry

研究点 (125)

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