A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 7
- 主要终点
- Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help docetaxel work better and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with hydroxychloroquine works in treating patients with metastatic prostate cancer.
详细描述
OBJECTIVES:
Primary
- To assess the antitumor activity, in terms of tumor response rate, of docetaxel in combination with hydroxychloroquine in patients with metastatic, hormone-refractory, chemotherapy-naive prostate cancer.
Secondary
- To measure time to disease progression and overall survival.
- To determine the feasibility and safety of this regimen in these patients.
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 120 Years（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
Docetaxel and Hydroxychloroquine
Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days.
干预措施: docetaxel (Drug)
Docetaxel and Hydroxychloroquine
Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days.
干预措施: hydroxychloroquine (Drug)
结局指标
主要结局
Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.
时间窗: 4 years
We will use a two-stage optimal Simon's design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The "expected" sample size of the trial is 23.5 with the null response rate of 50%.
次要结局
- Time to Disease Progression(10 years)
- Overall Survival(10 years)