Phase I-II Study Evaluating the Safety and Clinical Efficacy of Temsirolimus and Avastin in Patients With Chemotherapy Refractory Castrate Resistant Prostate Cancer (CRPC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose (MTD) of Temsirolimus (Phase I)
研究概览
简要总结
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may be a better way to block tumor growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with bevacizumab and to see how well it works in treating patients with hormone-resistant metastatic prostate cancer that did not respond to chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. The primary objective of the Phase I portion of this study is to determine the maximum tolerated dose (MTD) of temsirolimus in combination with AVASTIN in subjects with chemotherapy refractory metastatic CRPC.
II. The primary objective for the Phase II portion of this study is to evaluate the objective response frequency (PSA and RECIST-Response Evaluation Criteria in Solid Tumors-defined) of the combination of temsirolimus and AVASTIN in patients with chemotherapy refractory metastatic CRPC.
SECONDARY OBJECTIVES:
I. To evaluate the effect of the combination of temsirolimus and AVASTIN on time to clinical progression and overall survival in patients with chemotherapy refractory metastatic CRPC.
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
Arm 1: Combination of temsirolimus and AVASTIN
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: temsirolimus (Drug)
Arm 1: Combination of temsirolimus and AVASTIN
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Arm 1: Combination of temsirolimus and AVASTIN
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: polymorphism analysis (Genetic)
Arm 1: Combination of temsirolimus and AVASTIN
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Temsirolimus (Phase I)
时间窗: at 24 weeks
Participants received temsirolimus (20mg or 25mg IV weekly) in combination with a fixed dose of IV bevacizumab (10mg/kg every 2 weeks). The MTD was determined to be the dose at which no unacceptable toxicities were observed.
Objective Response (Dose Level 2)
时间窗: change from baseline to 12 weeks
PSA (Prostate-Specific Antigen) test will be performed every 4 weeks prior to receiving treatment. PSA response will be measured as the number of participants that had a decline observed from baseline.
次要结局
- Time to Clinical Progression(12 weeks)
- Overall Survival(baseline to end of study, up to 3.5 years)
- Number of Patients With Toxicity as Assessed by CTCAE v3.0 (Common Toxicity Criteria for Adverse Effects)(at 24 weeks)