NCT01210053Unknown2 期
This Phase II Trial is Studying Sunitinib to See How Well it Works When Given as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Which is Previously Treated With Combination Chemotherapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival
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. It is not yet known whether sunitinib is effective in treating non-small cell lung cancer.
PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as maintenance therapy in treating patients with stage III or stage IV non-small cell lung cancer which is previously treated with combination chemotherapy.
详细描述
OBJECTIVES:
Primary
- To investigate the effect of sunitinib malate on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer Secondary
- To evaluate the toxicity of sunitinib when administered in the maintenance setting.
- To evaluate the additional response rate to sunitinib malate when administered in the maintenance setting.
- To evaluate the overall survival of patients treated with sunitinib. After completion of study treatment, patients are followed every 2 months for 1 year, every 6 months for 1 year, and periodically for 3 years.
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
- •No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
- •Histologically or cytologically confirmed primary non-small cell lung cancer who have stable or responding disease after prior treatment with 3-6 courses of platinum -based therapy
- •Not a candidate for combined modality therapy
- •No cavitary lesions
排除标准
- •Evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
研究组 & 干预措施
Single arm
Experimental
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
干预措施: malate Given orally (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
次要结局
- • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival(2 years)
研究者
研究点 (1)
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