Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Time to Progression
研究概览
简要总结
RATIONALE: 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. Drugs used in chemotherapy, such as satraplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving satraplatin together with bevacizumab works in treating patients with metastatic prostate cancer previously treated with docetaxel.
详细描述
OBJECTIVES:
Primary
- Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab.
Secondary
- Determine the toxicity of this regimen in these patients.
- Assess the prostate-specific antigen (PSA) response rate in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) in patients treated with this regimen.
- Correlate urine NTX and serum BSAP levels with time to progression in patients treated with this regimen.
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
Bevacizumab and Satraplatin
Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days
干预措施: bevacizumab (Biological)
Bevacizumab and Satraplatin
Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days
干预措施: satraplatin (Drug)
结局指标
主要结局
Time to Progression
时间窗: Every 70 days
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit.
次要结局
- Percentage of Participants With Prostate-specific Antigen (PSA) Response(Day 1 of every cycle (35 days) and Day 15 of every cycle)
- Overall Survival(Followed every 3 months after treatment is discontinued)
- Toxicity, Presented as the Number of Participants With Adverse Events(Day 1 of every cycle (35 days) and Day 15 of every cycle)
研究者
Ulka Vaishampayan
Principal Investigator
Barbara Ann Karmanos Cancer Institute