Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- The objective response rate of brain metastases
研究概览
简要总结
The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
详细描述
Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
- •18 years or older
- •Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
- •Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
- •Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
- •Total bilirubin 1.5 x upper limit of normal (ULN)
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- •Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
- •If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.
排除标准
- •Mixed non-adenocarcinoma cell lung cancer histology
- •Previous treatment with pemetrexed or tarceva
- •Be allergic to pemetrexed or tarceva
研究组 & 干预措施
Erlotinib, pemetrexed, cisplatin
干预措施: erlotinib (Drug)
Erlotinib, pemetrexed, cisplatin
干预措施: pemetrexed (Drug)
Erlotinib, pemetrexed, cisplatin
干预措施: cisplatin (Drug)
erlotinib
干预措施: erlotinib (Drug)
结局指标
主要结局
The objective response rate of brain metastases
时间窗: Patients will be followed for an expected average of 6 weeks
次要结局
- Overall survival of patients(3 years after the first treatment)
- The disease control response rate of disease(Patients will be followed for an expected average of 6 weeks)
- Number of participants with adverse events as a measure of safety(2 years after first treatment)
- Progression-free survival of patients(2 years after first treatment)
研究者
Haihong Yang, MD, Pricipal investigator
The first affiliated hospital of Guangzhou MC
Guangzhou Medical University