A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Efficacy of the combination of Tarceva and Avastin
研究概览
简要总结
In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the treatment of patients with metastatic renal cell carcinoma. This trial will be one of the first phase II trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on Cancer Biology (VHL/HIF/VEGF/EGFr).
详细描述
Upon determination of eligibility, all patients will receive:
Tarceva + Avastin
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
- •To be included in this study, you must meet the following criteria:
- •Metastatic or unresectable clear cell kidney cancer confirmed by biopsy
- •Previous nephrectomy
- •Maximum of 1 previous regimen for metastatic disease
- •Ability to perform activities of daily living with minimal assistance
- •Measurable disease
- •Adequate bone marrow, liver and kidney function
- •Give written informed consent prior to study entry
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Age < 18 years
- •Treatment with more than one previous regimen for metastatic disease
- •Clinically significant cardiovascular disease
- •Active brain metastases
- •History of CNS disease
- •Clinical history of coughing or vomiting blood.
- •History of thromboembolic disease.
- •PEG or G-tube are ineligible.
- •Current use of full dose anticoagulants or thrombolytic agents
- •Chronic daily treatment with aspirin or NSAIDS
- •Any clinical evidence or history of a bleeding or clotting disorder
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
研究组 & 干预措施
OSI-774 & bevacizumab
OSI-774 (Tarceva) 150mb PO, days 1-28; bevacizumab (Avastin) 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days.
干预措施: OSI-774 (Drug)
OSI-774 & bevacizumab
OSI-774 (Tarceva) 150mb PO, days 1-28; bevacizumab (Avastin) 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Efficacy of the combination of Tarceva and Avastin
时间窗: 18 months
次要结局
- Objective response rate(18 months)
- Progression-free survival(18 months)
- Overall Survival(18 months)
- Overall tolerability and toxicity of this combination regimen(18 months)