A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With 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
- 48
- 试验地点
- 9
- 主要终点
- Response rate
研究概览
简要总结
This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer
详细描述
Intravenous (IV) vinorelbine is a standard chemotherapy option for the treatment of metastatic NSCLC, either alone or in combination with other agents such as CDDP or Carboplatin with overall response rates (ORR) of 15-35% as 1st line treatment and less than 10% as salvage treatment. For the past few years vinorelbine is available for per os (po) administration with acceptable and reliable pharmacokinetic profiles and with a bioavailability of approximately 40% of the IV dose. In randomized phase II studies IV and po vinorelbine have shown comparable response and overall survival rates. The low dose metronomic chemotherapy that is administered in short intervals has been shown in vitro an in vivo to have antiangiogenic effects. Bevacizumab is a well known anti-angiogenic agent. 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. This study will evaluate the combination of metronomic vinorelbine and bevavizumab as 2nd 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, metastatic (stage IV) non small cell lung cancer
- •One previous platinum based chemotherapy regimen with or without taxanes for metastatic NSCLC
- •Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
- •Age ≥ 18 years
- •Performance status (WHO) 0-2
- •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
- •Written informed consent
排除标准
- •Second primary malignancy, except for non-melanoma skin 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)
- •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
- •Serum Να+ < 120mg/dL
研究组 & 干预措施
1
Vinorelbine metronomic + bevacizumab
干预措施: Vinorelbine (Drug)
1
Vinorelbine metronomic + bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Response rate
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
次要结局
- Toxicity profile(Toxicity assessment on each cycle)
- Progression free survival(1 year)
- Overall survival(1 year)