NCT00582634已完成2 期
Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
- To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer
- To evaluate the time to progression and overall survival
- To evaluate toxicities of this chemotherapy combination in the adjuvant setting
- To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
- •Performance Status ECOG 0 or 1
- •Peripheral neuropathy: < grade 1
- •Adequate blood cell counts
- •Adequate liver and hepatic function
- •Women of childbearing potential must have a negative pregnancy test.
- •Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
排除标准
- •Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate
- •Women who are breast-feeding.
- •Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
- •Uncontrolled cardiac disease or uncontrolled hypertension
研究组 & 干预措施
Docetaxel followed by cisplatin
Experimental
Docetaxel (75mg/m2) given IV followed by cisplatin (75mg/m2) given IV on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for 4 cycles.
干预措施: docetaxel and cisplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: 36 months
Time to progression
时间窗: 36 months
Incidence of adverse events
时间窗: Baseline to 36 months
次要结局
- Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities(36 months)
研究者
研究点 (1)
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