NCT01531790已完成1 期
A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC
- •At least one measurable lesion (RECIST criteria)
- •Life expectancy > 3 months
- •ECOG performance status 0-2
- •Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
- •Adequate renal, hepatic and coagulation function
- •Written informed consent
排除标准
- •With uncontrollable malignant pleural effusion or ascites
- •Thoracic or abdominal surgery within 28 days prior to study entry
- •History of cerebral stroke or TIA within 6 months prior to study entry
- •With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
- •Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (> NYHA class II)
- •With serious infection (> NCI CTC grade 2)
- •Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry
- •Symptomatic brain metastases
- •Patient who has epilepsy
- •History of HIV infection or chronic hepatitis B or C
- •Allergic to any of the study drugs
- •Pregnant or lactating women
研究组 & 干预措施
Endostar plus pemetrexed/carboplatin
Experimental
21 days as one cycle, for a total of 4-6 cycles
干预措施: Carboplatin (Drug)
Endostar plus pemetrexed/carboplatin
Experimental
21 days as one cycle, for a total of 4-6 cycles
干预措施: Pemetrexed (Drug)
Endostar plus pemetrexed/carboplatin
Experimental
21 days as one cycle, for a total of 4-6 cycles
干预措施: Endostar (Drug)
Endostar plus pemetrexed/carboplatin
Experimental
21 days as one cycle, for a total of 4-6 cycles
干预措施: Centrum (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: up to 21 days
次要结局
- Objective Response Rate(up to 6 cycles)
- Disease Control Rate(up to 6 cycles)
- Progression-free Survival(up to 2 years)
- Overall Survival(up to 2 years)
研究者
研究点 (1)
Loading locations...
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