A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Response Rate of PS-341 in colon cancer
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib.
- Determine the time to tumor progression and 1-year survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo core biopsy.
- Arm II: Patients undergo core biopsy. Patients then receive bortezomib IV as in arm I.
Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
Pre-Treatment biopsy followed by PS-341 administration
Pre-treatment tumor biopsy followed by 3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects can continue to receive another 3 cycles of the study drug if their disease has not worsened.
干预措施: PS-341 (Drug)
Pre-Treatment biopsy followed by PS-341 administration
Pre-treatment tumor biopsy followed by 3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects can continue to receive another 3 cycles of the study drug if their disease has not worsened.
干预措施: Tumor Biopsy (Procedure)
PS-341 administration followed by biopsy
3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects will have a tumor biopsy and can continue to receive another 3 cycles of the study drug if their disease has not worsened.
干预措施: PS-341 (Drug)
PS-341 administration followed by biopsy
3 cycles of PS-341 given by IV infusion. Each cycle will last 3 weeks. PS-341 will be given 2 times a week for 2 weeks followed by a 'rest' week with no drug. After the 3rd cycle, subjects will have a tumor biopsy and can continue to receive another 3 cycles of the study drug if their disease has not worsened.
干预措施: Tumor Biopsy (Procedure)
结局指标
主要结局
Response Rate of PS-341 in colon cancer
时间窗: 9 weeks
次要结局
未报告次要终点