NCT01017679已完成2 期
Phase II Multi-centre Randomized Controlled Study of Gefitinib 500mg Versus 250mg in Patients With NSCLC With Stable Disease After a Month Treatment of Gefitinib 250mg
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Comparing the difference of Response rate(CR & PR)
研究概览
简要总结
This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib 500mg in patients with IIIB/IV staged non-small cell lung cancer(NSCLC) with stable disease after a month treatment of 250mg Gefitinib by DCR,also PFS and OS.The side effect is evaluated as well.
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
- •Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- •received at least one chemotherapy regimen
- •with stable disease after a month treatment of gefitinib(CT scan)
- •the radiotherapy focus is not the measurable disease within 4 weeks.the patients received palliative therapy can be included.
- •Age >18 years, either sex
- •with a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) at least according to RECIST Criteria
- •WHO performance status(PS)<= 2 ( Patients Whit PS=2 Should not get worsen within 2 weeks Before Included)
- •N>=1.5×109/L, Plt>=1.5×109/L,Hb>=10g/dL
- •ALP<2.5×ULN.If ALP>=2.5ULN, AST&ALT should <1.5ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN，AST&ALT<2.5ULN(without liver metastasis) or <5ULN (with liver metastasis).
- •Signed and dated informed consent before the start of specific protocol procedures.
- •recruiting and receiving treatment in 5 days after last CT scan
- •Patients able to taken oral drug
排除标准
- •Life expectancy <= 12 weeks.Patients with metastatic brain tumors without symptoms or had been treated can be included.
- •experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
- •can not take drug orally, have active peptic ulcer,half upper gastrointestinal or have dyspepsia.
- •allergic to gefitinib
- •Prior exposure to drugs without approval from this research or other study drugs within 21days before the 1st day taken Gefitinib 500mg or 250mg.
- •Pregnant or breast-feeding women
- •Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except of cervical carcinoma in situ,basal cell carcinoma within 5 years prior to study entry.
研究组 & 干预措施
1
Experimental
Oral Drug gefitinib(Iressa) 500 mg Everyday
干预措施: Gefitinib 500mg/Gefitinib 250mg (Drug)
2
Active Comparator
Oral Drug gefitinib(Iressa) 250 mg Everyday
干预措施: Gefitinib 500mg/Gefitinib 250mg (Drug)
结局指标
主要结局
Comparing the difference of Response rate(CR & PR)
时间窗: 3 years
次要结局
- Comparing the difference of PFS(Progression Free Survival)and OS(Overall Survival) in two arms(3 and a half years)
研究者
Li Zhang
Profressor
Sun Yat-sen University
研究点 (1)
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