Pemetrexed Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Progression Free Survival
研究概览
简要总结
This trial will evaluate the efficacy and safety of pemetrexed and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer (NSCLC).
详细描述
Pemetrexed is and an effective and well tolerated cytotoxic agent in the 2nd line treatment of advanced or metastatic non small cell lung cancer (NSCLC). Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. This study will evaluate the combination of pemetrexed and bevacizumab as 2nd or 3rd line treatment of NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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,
- •Unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
- •At least one and no more than two previous chemotherapy regimens for advanced - or metastatic NSCLC
- •Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm.
- •Age ≥ 18 years.
- •Performance status (WHO) 0-
- •Life expectancy of at least 12 weeks.
- •Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 Upper normal limit, SGOT/SGPT ≤ 2.5 Upper normal limit in the absence of liver metastases or ≤ 5 Upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 Upper normal limit).
- •Patients must be able to understand the nature of this study and give written informed consent
排除标准
- •Previous therapy with pemetrexed
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- •Pregnant or lactating women
- •Any serious, uncontrolled comorbidity on the investigator's judgment. Uncontrolled infection
- •Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
- •Symptomatic neuropathy > grade 2 according to the NCI CTCAE (version 3.0)
- •Brain metastases, except if radiated and asymptomatic
- •Radiotherapy within the previous 4 weeks
- •Previous radiotherapy to the only measurable lesion
- •Proteinuria ≥ 500 mgr of protein daily
- •Hemoptysis > 10 cc per event
- •Clinically significant hematemesis
- •Centrally located lesion or in contact with major vessels
- •Pulmonary lesion with cavitation
- •Documented hemorrhagic diathesis or coagulation disorder
- •Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular arrhythmia, uncontrolled hypertension)
- •Thrombotic event within the previous 6 months
- •Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
- •Concurrent treatment with other anti-cancer drug
- •Major surgical procedure within the previous 4 weeks
研究组 & 干预措施
1
Pemetrexed/Bevacizumab
干预措施: Pemetrexed (Drug)
1
Pemetrexed/Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 1 year
次要结局
- Overall Survival(1 year)
- Overall response rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Quality of life assessment(Assessment every two cycles)
- Toxicity profile(Assessment every two cycles)