A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 245
- 主要终点
- Confirmed Prostate-Specific Antigen (PSA) Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, 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.
PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
详细描述
OBJECTIVES:
Primary
- Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody.
Secondary
- Assess overall survival and progression-free survival of these patients.
- Assess the objective response rate (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with this regimen.
- Assess the qualitative and quantitative toxicities of 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 —（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
结局指标
主要结局
Confirmed Prostate-Specific Antigen (PSA) Response
时间窗: Assessed every 3 cycles (1 cycle = 14 days) until progression
PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.
次要结局
- Progression-free Survival (PFS)(Assessed every 3 cycles (1 cycle = 14 days) until progression)
- Overall Survival (OS)(0-3 yeas after registration)
- Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease(Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression)
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug(Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment)