NCT00038194已完成1 期
Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical research study is to find the highest safe dose of docetaxel in combination with Gleevec (imatinib mesylate) that can be given to men with advanced androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial chemotherapy which interferes with the cancer cell ability to divide and grow.
详细描述
OBJECTIVES:
- To define the maximum tolerated dose of weekly docetaxel in combination with fixed-dose oral STI571 in adult men with metastatic androgen-independent prostate cancer (AIPC).
- To determine the qualitative and quantitative toxicity of the combination of oral STI571 and docetaxel.
- Evaluate PSA modulation with STI571 alone at thirty days in patients with AIPC.
- Obtain a preliminary estimate of the response rate in AIPC to the combination of STI571 and docetaxel.
- Obtain tissue for correlative science studies (these are optional studies).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 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
Imatinib + Docetaxel
Experimental
干预措施: imatinib mesylate (Drug)
Imatinib + Docetaxel
Experimental
干预措施: docetaxel (Drug)
研究者
研究点 (1)
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