A Phase II Study to Evaluate the Efficacy and Safety of Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer
研究概览
简要总结
The purpose of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)
详细描述
The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors, including NSCLC.Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. EGFR-targeted cancer therapies are currently being developed; strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE). Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIB/IV NSCLC
- •No immediate need for palliative radiotherapy and No prior chemotherapy
- •age > 20 Y/O
- •ECOG PS: 0 - 2
- •ANC >2000
- •PLT >100k
- •total bilirubin < 2.0 mg/dL
- •serum creatinine < 2 mg/dl
- •SGPT and SGOT < 2.5 ×ULN, alkaline phosphatase < 5 ×ULN
- •life expectancy >6mos.
排除标准
- •If the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy
- •2nd malignancies
- •Unable to swallow tablets
- •Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
- •Pregnant or lactating patients
- •Participation in other clinical trials within 30 days of study entry
- •Major systemic disease which in the investigator's opinion might confound the clinical trial
研究组 & 干预措施
A
Iressa
干预措施: Iressa (Drug)
结局指标
主要结局
The primary objective of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer
时间窗: 2005~2007
次要结局
- To evaluate 1) Individual response rate 2) Time to progression 3) Overall survival (OS) at year1 4) Progression free survival (PFS) at year1 5) Toxicity(2005~2007)