NCT00181597已完成2 期
A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
Genzyme, a Sanofi Company4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2004年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- activity of trilostane in men with androgen-independent prostate cancer.
研究概览
简要总结
The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.
详细描述
- Patients will take trilostane orally once a day for three days, then twice a day thereafter.
- Patients will complete a daily drug log recording the date, time and number of capsules taken.
- Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
- While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
- Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
- Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.
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
- •Histologically confirmed prostate adenocarcinoma
- •Disease progression despite androgen depravation therapy and antiandrogen withdrawal
- •Progressive measurable disease or bone scan progression or PSA progression
- •Serum total testosterone < 50ng/ml
- •Creatinine < 2.0 mg/dl
- •ALT < 2 x ULN
- •CALGB performance status of 0,1, or 2
排除标准
- •Radiation therapy within 4 weeks
- •Antiandrogen within 8 weeks
- •Other secondary hormonal therapy or investigational agents within 4 weeks
- •Prior chemotherapy for androgen-independent prostate cancer
- •History of adrenal insufficiency
- •Known brain metastases
- •Severe liver or renal disease
结局指标
主要结局
activity of trilostane in men with androgen-independent prostate cancer.
时间窗: 4 years
次要结局
- serum levels of gonadal and adrenal steroids(4 years)
研究者
研究点 (4)
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