A Pilot Phase I/II Study to Evaluate the Effects of Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients With Biochemical Relapse
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Prostate Specific Antigen (PSA) Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells.
PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the response by prostate specific antigen (PSA) of docetaxel/prednisone plus sunitinib (sunitinib malate) in chemotherapy-naive, hormone refractory prostate cancer subjects with biochemical relapse.
SECONDARY OBJECTIVES:
I. To determine the objective response rate (ORR) and duration of response (DR) in subjects with measurable disease.
II. To determine overall survival (OS) and time to progression (TTP). III. To evaluate the safety and tolerability of sunitinib in combination with docetaxel and prednisone.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Chemotherapy and enzyme inhibitor
Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
干预措施: prednisone (Drug)
Chemotherapy and enzyme inhibitor
Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
Chemotherapy and enzyme inhibitor
Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
干预措施: docetaxel (Drug)
结局指标
主要结局
Prostate Specific Antigen (PSA) Response Rate
时间窗: Baseline, every 3 weeks, at study termination, and then for 3 years
Defined by \>= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.
次要结局
- Survival(At 2 and 3 years)
- Qualitative and Quantitative Toxicity(Every 3 weeks and at study termination)
- Time to Progression (TTP) by PSA Response and Disease Response(Baseline, every 3 weeks, at study termination, and then for 3 years)
- Rates of Tumor Response (ORR)(Every 2 months)
- Duration of Response (DR)(Up to 3 years)
研究者
John P. Fruehauf
Dr. John P. Fruehauf
University of California, Irvine