A Phase II Study Of Estramustine, Docetaxel, And Exisulind (IND #64733) In Men With Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 80
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining these therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the time to objective and biochemical progression and response proportion (objective and post-therapy changes in PSA) in patients with hormone refractory metastatic prostate cancer treated with docetaxel, estramustine, and exisulind.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5, docetaxel IV over 1 hour on day 2, and oral exisulind twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
干预措施: docetaxel (Drug)
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
干预措施: estramustine phosphate sodium (Drug)
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
干预措施: exisulind (Drug)
结局指标
主要结局
Time to progression
时间窗: 24 months from study entry
次要结局
- Changes in PSA(During treatment then q 3 mon until ds progression)
- Overall Survival(24 months from study entry)
- Toxicity(treatment up to 3 mon post treatment)