A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PSA response
研究概览
简要总结
This is a single-arm, open label phase II trial of the investigational agent, Ara-C (cytarabine), in patients diagnosed with hormone refractory prostate cancer whose disease has progressed on or deemed not suitable for standard chemotherapy with docetaxel. Ara-C appears to inhibit DNA synthesis and is cytotoxic to a wide variety of mammalian cells. Recent discoveries have suggested the role of gene fusions in the ETS family of transcription factors as important for the development of prostate cancer. Ara-C appears to block ETS genes, suggesting that it is worthwhile to explore Ara-C as a potential new treatment for patients with hormone refractory prostate cancer given that there is no standard of care for the proposed patient population. In this study, Ara-C will be administered intravenously for 2 days every 3 weeks (1 cycle). Treatment will be for 6 cycles if tolerated and may be continued in patients who are responding and do not have severe toxicity.
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
- •Biopsy-proven prostate cancer or clinical picture consistent with metastatic prostate cancer with high level of serum PSA (> 20ng/ml)
- •At least 4 weeks after docetaxel treatment and have at least 2 consecutive rising PSAs measured at least 2 weeks apart
- •Progression on or intolerance of docetaxel chemotherapy
- •ECOG performance status ≤ 2
- •Adequate organ and marrow function
排除标准
- •Prior treatment with cytarabine
- •Receiving any other investigational or anticancer agents
- •Uncontrolled intercurrent illness
- •Active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
- •Radiotherapy within the past 4 weeks
研究组 & 干预措施
Cytarabine
eligible patients will receive cytarabine, starting at 075g/m2 and escalating to a maximum of 1.25g/m2, BID IV for 2 days every three weeks for 6 or more cycles if tolerated.
干预措施: Cytarabine (Drug)
结局指标
主要结局
PSA response
时间窗: 50% decline in PSA from baseline, confirmed by a second measurement ≥3 weeks later
PSA levels will be collected at screening, baseline, 2 weeks following study termination, and upon followup to determine PSA level response to treatment.
次要结局
- Pain response(Baseline median PPI with no concomitant increase in analgesic score/pain)
- QOL response(Baseline to two measurements obtained at least three weeks apart)
- Measurable disease response(Every 3 cycles (9 weeks))
- PSA progression free survival(Baseline and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first.)