NCT00814021已完成2 期
Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer
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
- 21
- 试验地点
- 1
- 主要终点
- Objective response rate in the brain after 2 courses
研究概览
简要总结
RATIONALE: Sunitinib 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 sunitinib works in treating patients with kidney cancer that has spread to the brain.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in the brain after 2 courses of sunitnib malate in patients with previously untreated or recurrent brain metastases secondary to renal cancer following radiotherapy or surgery.
Secondary
- Evaluate duration of response.
- Evaluate objective response of non-CNS targets.
- Evaluate time to disease progression.
- Evaluate overall and progression-free survival.
- Evaluate neurological symptoms associated with the tumor.
- Evaluate feasibility and overall tolerance of this drug.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the kidney
- •Metastatic disease
- •Measurable disease by RECIST criteria
- •Presence of previously untreated or recurrent brain metastases following radiotherapy or surgery
- •No brain metastasis revealed by hemorrhage
- •No single brain metastasis < 2 cm that is accessible by surgery or radiosurgery
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2 (unless paresis due to brain metastases)
- •ANC > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 8 g/dL
- •PT or INR < 1.5 times upper limit of normal (ULN)
- •AST/ALT < 2.5 times ULN (< 5 times ULN in the case of liver metastases)
- •Total bilirubin < 1.5 times ULN
- •Serum creatinine < 200 μmol/L
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for up to 30 days following completion of study treatment
- •No other cancer except for in situ cervical cancer, curatively treated basal cell carcinoma of the skin, or other curatively treated cancer without evidence of recurrence within the past 5 years
- •No uncontrolled hypertension (systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 90 mm Hg)
- •None of the following cardiac conditions within the past 6 months:
- •Significant cardiovascular disease
- •NYHA class III-IV congestive heart failure
- •Myocardial infarction
- •Unstable angina
- •Severe arrhythmia
- •Cerebrovascular accident
- •Severe thromboembolism
- •No serious neuropsychiatric disease
- •No psychological, familial, social, or geographic situations that preclude clinical follow-up
- •No patient deprived of liberty by a court or administrative order
- •Able to understand French
- •PRIOR CONCURRENT THERAPY:
- •At least 6 months since prior antineoplastic treatment with sunitinib malate
- •At least 4 weeks since other prior treatment
- •At least 3 weeks since prior hematopoietic growth factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])
- •No concurrent antivitamin K at curative or anticoagulation doses
排除标准
- 未提供
研究组 & 干预措施
sunitinib,
Experimental
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Objective response rate in the brain after 2 courses
时间窗: From beginning of treatment until 2 courses of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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