Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- PSA Response rate
研究概览
简要总结
The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.
详细描述
The investigators propose a simple phase II trial of oral colchicine at the standard prophylactic dose utilized for gout in men with CRPCa who have failed taxotere based chemotherapy. The investigators will utilize a simple modified Simon 2-stage design. The investigators plan to enroll 40 men for the study. The men should have completed prior taxotere based therapy or any other therapy post-taxotere including cabazitaxel one month prior to receipt of colchicine on trial. Staging with a baseline bone scan, CT and PSA as well as routine CBC, CMP and PAP. The dose of the drug can be escalated as tolerated to a maximum of 1.2 mg bid. The patient would be seen at 21 day intervals. After every 3 cycles of treatment, patient would be restaged with CT and bone scan. Patients with stable disease, partial response or complete response would continue therapy until either disease progression or intolerable toxicity after which the patient would be taken off study.
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
- 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
- •Castrate resistant prostate cancer
- •Failure or intolerance of taxotere or cabazitaxel-based chemotherapy or abiraterone administered for castrate resistant prostate cancer is allowed
- •Age > 18 years and ability to provide informed consent
- •ECOG performance status of 0, 1 or 2
- •No prior use of colchicine within the last 2 years
- •No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of day 1, cycle 1
排除标准
- •Inability to provide informed consent
- •Hypersensitivity to colchicine
- •Severe renal, gastrointestinal or hepatic disorders
- •Pre-existing blood dyscrasia
- •PLT < 100K, ANC < 1000
- •Serum Cr > 2 x ULN
- •Bilirubin > 2 ULN
- •AST > 2 x ULN
- •Concurrent use of CYP3A4 inhibitors which may increase drug levels and toxicity
研究组 & 干预措施
Single arm
Colchicine 0.5 mg BID x 21 days
干预措施: Colchicine (Drug)
结局指标
主要结局
PSA Response rate
时间窗: 63 days (3 cycles of treatment)
Determine the PSA response rate to continuous low dose oral colchicine
次要结局
- Response rate(63 days (3 cycles))
- Toxicity grading(One year)
研究者
Joseph Drabick
Professor of Medicine
Milton S. Hershey Medical Center
