NCT00294931已完成2 期
A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- median time to progression
研究概览
简要总结
This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.
详细描述
Eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. The interval between chemotherapy courses will be 28 days. If after 6 courses of treatment, patient's response is a CR/PR/SD they will continue on Bevacizumab until tumor progression or up to 6 cycles (6 months) total.
Treatment sequence:
- Irinotecan 60mg/m2 on days 1, 8, and 15
- Carboplatin AUC=4 day 1 only
- Bevacizumab 10 mg/kg days 1 and 15
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed small cell lung cancer,extensive stage disease.
- •Measurable or evaluable disease
- •No previous chemotherapy
- •Able to perform activities of daily living with minimal assistance
- •Adequate hematological, live and kidney function
- •Provide written informed consent
排除标准
- •Limited stage disease
- •PEG or G tubes
- •Hemoptysis
- •Abdominal fistula, perforation, or abscess within the previous 6 months
- •Women who are pregnant or lactating
- •Proteinuria
- •Serious nonhealing wound, ulcer, or bone fracture
- •Evidence of bleeding diathesis or coagulopathy
- •Uncontrolled or serious cardiovascular disease
- •Uncontrolled brain metastasis
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days; Fine needle aspiration within 7 days
- •Patients requiring full-dose anticoagulation must be on a stable dosing schedule prior to enrollment
结局指标
主要结局
median time to progression
次要结局
- duration of response
- overall survival
- overall toxicity
- overall response rate
研究者
研究点 (8)
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