NCT01192230Unknown2 期
A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
适应症
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
- Response rate
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
- •≥ 18 years old
- •patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
- •At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
- •have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
- •Expected life time longer than 3 months
- •Normal laboratory values:
- •leucocyte≥ 4×109/L
- •neutrophil≥ 1.5×109/L
- •platelet≥90×109/L
- •Hemoglobin≥ 9g/L
- •ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
- •serum creatinine<1.5 mg/dl
- •bilirubin <1.5×ULN
- •No allergy to biological drug
- •Sign the consent forms
排除标准
- •Patients who have previously received Docetaxel or anti-VEGF inhibitors
- •Severe symptomatic heart disease
- •Female patients during their pregnant and lactation period, or patients without contraception
- •Severe uncontrolled infection
- •Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
- •Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
- •Patients have accepted other clinical trials
结局指标
主要结局
Response rate
时间窗: six weeks
Progression free survival
时间窗: six weeks
Overall survival
时间窗: three months
次要结局
- Quality of Life(six weeks)
研究者
研究点 (1)
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