An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 37
- 主要终点
- Rate of grade >=3 Avastin-related pulmonary hemorrhage
研究概览
简要总结
This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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
- •adult patients, >=18 years of age;
- •documented squamous non-small cell lung cancer;
- •stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;
- •suitable for platinum-based treatment as first line chemotherapy.
排除标准
- •prior systemic anti-tumor therapy;
- •prior radiotherapy for treatment of patient's current stage of disease;
- •other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
- •major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: Platinum-based chemotherapy (Drug)
结局指标
主要结局
Rate of grade >=3 Avastin-related pulmonary hemorrhage
时间窗: After a maximum of 12 months treatment
次要结局
- Overall response, duration of response, progression-free survival.(Event driven)
- AEs, laboratory parameters, coagulation parameters.(Throughout study)