NCT00276614已完成2 期
A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
研究概览
简要总结
RATIONALE: Bortezomib 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.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment.
Secondary
- Correlate clinical response in these patients with baseline von Hippel-Lindau expression and nuclear factor-KB activity.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)
- •Distant metastatic disease (Tx, Nx, M1)
- •Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein
- •Measurable disease on imaging scan (≥ 1 cm)
- •Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy.
- •Life expectancy ≥ 3 months
- •Karnofsky performance status ≥ 60%
- •Negative pregnancy test
- •Fertile patients must use an acceptable method of contraception
- •No other major illnesses likely to limit survival
- •Platelet count ≥ 100,000/mm^3
- •Absolute neutrophil count ≥ 1, 000/mm^3
- •Hemoglobin ≥ 10 g/dL (transfusion allowed)
- •Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL
- •ALT or AST ≤ 2.5 times upper limit of normal
- •At least 4 weeks since prior radiotherapy and recovered
- •More than 30 days since any other prior investigational drugs
排除标准
- •active CNS metastases
- •pregnant or nursing
- •myocardial infarction within the past 6 months
- •New York Heart Association class III or IV heart failure
- •uncontrolled angina
- •severe uncontrolled ventricular arrhythmias
- •electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Peripheral neuropathy ≤ grade 1
- •hypersensitivity to bortezomib, boron, or mannitol
- •history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin
- •serious medical or psychiatric illness that would preclude study participation
- •prior cytotoxic chemotherapy for this cancer
- •other concurrent investigational therapy
- •concurrent chemotherapy, immunotherapy, or hormonal therapy
研究组 & 干预措施
Velcade
Experimental
Velcade IV twice a week for two weeks on Days 1, 4, 8 and 11 of each cycle. A 10 day-rest period (Days 12-21) with no Velcade will follow the 2 weeks of treatment in each cycle. one cycle = 21 days
干预措施: bortezomib (Drug)
结局指标
主要结局
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
时间窗: 2 months
次要结局
未报告次要终点
研究者
研究点 (1)
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