NCT00150657Unknown2 期
Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer
St. John Providence Health System2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- time to progression
研究概览
简要总结
- this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added
- the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)
- all patients receive all three drugs; there is no placebo
详细描述
- Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.
- Patients with brain metastases, squamous histology, or hemoptysis are excluded.
- All patients must give informed consent.
- Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles
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 or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy
- •Stage IV disease or stage IIIB with a malignant pleural effusion
- •measurable or evaluable disease
- •Performance status 0 or 1 (ECOG)
- •adequate renal, hepatic, and bone marrow function
- •adequate recovery from previous surgery or radiotherapy
- •informed consent
排除标准
- •brain metastases
- •squamous (epidermoid) histology
- •hemoptysis
- •central airway disease
- •Pancoast tumors
- •previous chemotherapy or biologic therapy for lung cancer
- •prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS
- •pregnant or nursing women
结局指标
主要结局
time to progression
次要结局
- response rate
- median survival
- one year survival
- two year survival
- toxicity
研究者
研究点 (2)
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