A Phase II Study of Second-Line Therapy With Irinotecan or Gefitinib in Docetaxel Pretreated Patients With Non-Small Cell Lung Cancer: a New Treatment Strategy According to Clinical Predictors for Response
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.
详细描述
It has been suggested that some clinical parameters, including women, no smoking history and a histologic diagnosis of adenocarcinoma, are associated with favorable outcomes of gefitinib therapy. We will conduct a phase II study in docetaxel pretreated advanced NSCLC patients treated with gefitinib or irinotecan according to these clinical parameters in order to determine whether in patients with favorable clinical parameter(s) gefitinib will produce difference outcomes from patients without favorable clinical parameter treated with irinotecan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 75 years or less
- •histologically or cytologically confirmed non-small cell lung cancer
- •advanced, metastatic or recurrent
- •ECOG performance status 0 to 2
- •one prior palliative chemotherapy including docetaxel
- •measurable or evaluable indicator lesion(s)
- •normal marrow, hepatic and renal function
- •provision of written informed consent
排除标准
- •active infection and/or severe comorbidities
- •pregnant or breastfed women
- •active CNS metastasis
- •active bleeding in GI tract or elsewhere
结局指标
主要结局
Objective response rate
Progression-free survival
次要结局
- Overall survival
- Toxicity