NCT00440414已完成3 期
A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)
Hellenic Oncology Research Group9 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 9
- 主要终点
- Time to Tumor Progression
研究概览
简要总结
The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
详细描述
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer adenocarcinoma
- •Stage IIIB/IV
- •Failure to prior chemotherapy
- •Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- •Absence or irradiated and stable central nervous system metastatic disease.
- •Life expectancy of more than 3 months
- •Tissue sample desired for genomic study
- •Age ≥ 18 years
- •Performance status (WHO) < 3
- •For patients > 65 years old: "non-frail" according to comprehensive geriatric assessment
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- •Presence of a reliable care giver for patients > 65 years old
- •Informed consent.
排除标准
- •Psychiatric illness or social situation that would preclude study compliance
- •Other concurrent uncontrolled illness
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
研究组 & 干预措施
1
Experimental
Alimta
干预措施: Pemetrexed (Alimta) (Drug)
2
Experimental
Tarceva
干预措施: Erlotinib (Tarceva) (Drug)
结局指标
主要结局
Time to Tumor Progression
时间窗: 1 year TTP
次要结局
- Overall response rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Overall survival between the two treatment arms(1 year OS)
- Quality of life assessment(Assessment every two cycles)
- Toxicity profile between the two treatment arms(Toxicity assessment on each chemotherapy cycles)
研究者
研究点 (9)
Loading locations...
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