NCT00076388已完成3 期
A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,440
- 试验地点
- 163
- 主要终点
- To compare overall survival between ZD1839 and docetaxel
研究概览
简要总结
The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
- •Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- •Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
- •WHO performance status (PS) 0-2
- •Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L
- •Life expectancy of at least 8 weeks
排除标准
- •Prior ZD1839 therapy
- •Prior docetaxel treatment for NSCLC
- •Less than 14 days since completion of prior radiotherapy
- •Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
- •Evidence of clinically active Interstitial Lung Disease
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
- •Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)
结局指标
主要结局
To compare overall survival between ZD1839 and docetaxel
次要结局
- To compare time to progression (TTP) between ZD1839 and docetaxel
- To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
- To compare the overall objective tumor response rate between ZD1839 and docetaxel
- To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
- To compare safety and tolerability of ZD1839 and docetaxel
研究者
研究点 (163)
Loading locations...
相似试验
已完成
3 期
Docetaxel in Breast CancerBreast CancerNCT00312208Sanofi3,299
已完成
2 期
AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC PatientsNon Small Cell Lung CancerNCT00890825AstraZeneca88
已完成
2 期
ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck CancerHead and Neck CancerNCT00242762AstraZeneca36
已完成
2 期
Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate CancerProstate CancerNCT00242918Benaroya Research Institute29
已完成
2 期
Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and NeckSquamous Cell Carcinoma of Head and NeckNCT00459043Dana-Farber Cancer Institute30