NCT00953459终止2 期
Phase II Study of Sunitinib (SU011248) in Patients With Small Cell Lung Cancer Who Are Either Chemo-naïve (Extensive Disease) or Have a "Sensitive" Relapse
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2009年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria
研究概览
简要总结
RATIONALE: Sunitinib malate 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 malate works in treating patients with small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.
Secondary
- To characterize the safety of sunitinib malate in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 confirmed small cell lung cancer
- •Chemotherapy naïve (extensive stage) OR sensitive relapse (> 3 months since induction therapy) disease
- •Measurable disease, as defined by RECIST criteria
- •No brain metastases as assessed by CT scan or MRI performed < 1 week before treatment
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy > 12 weeks
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •AST and ALT ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver function abnormalities are due to underlying malignancy)
- •Total serum bilirubin ≤ 1.5 x ULN
- •Serum albumin ≥ 3.0 g/dL
- •Negative pregnancy test
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after study treatment
- •No spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- •No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within the past 6 months
- •No NCI CTCAE grade 3 hemorrhage within the past 4 weeks
- •No hypertension (> 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents
- •No ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for females
- •No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior chemotherapy, surgery, or investigational agents
- •At least 1 month since prior radiotherapy except for palliative radiotherapy to non-target lesions
- •No prior treatment with sunitinib malate (SU011248) or other receptor tyrosine kinase inhibitors
- •No concurrent treatment with steroids
- •No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide)
- •More than 7 and 12 days and no concurrent potent CYP3A4 inhibitors and inducers, respectively
- •Concurrent coumarin-derivative anticoagulants, such as warfarin (Coumadin®) up to 2 mg daily are permitted for prophylaxis of thrombosis
- •No other concurrent anticancer treatments, including chemotherapy, immunotherapy, targeted agents, hormonal cancer therapy, radiation therapy, or experimental treatments
排除标准
- 未提供
结局指标
主要结局
Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria
次要结局
- Response rate every 4 weeks according to RECIST criteria
- Duration of progression-free survival
- Duration of response
- Duration of survival
- Toxicity according to NCI CTCAE version 3.0
- Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response
研究者
研究点 (1)
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