Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Nab-paclitaxel as a Single Agent in the Small Cell Lung Cancer Patients With Extensive Disease and Failed to First Line/ Second Line Chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. Most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited efficacy to these patients. Currently, there is no standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).
As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases report in the patients with SCLC, the aim of this clinical trial is to investigate the efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive disease and failed to first line/ second line chemotherapy.
详细描述
Primary end point: Objective Response Rate(ORR)
Secondary end point:
Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtain of informed consent.
- •Male or female aged 18 years and over.
- •Histologically or cytologically confirmed small cell lung carcinoma.
- •Extensive disease before receive nab-paclitaxel.
- •Failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not allowed.
- •World Health Organization (WHO) performance status (PS) of 0 to
- •Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
- •Heart index values is in the range, as defined below, within two weeks of randomization:
- •Absolute neutrophils count(ANC)≥2.0×109/L
- •Platelets≥100×109/L
- •Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT) ≤2.5×ULN(≤5×ULN if liver metastases)
- •Creatinine clearance≥60ml/min
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria with at least one measurable lesion not previously irradiated.
- •Life expectancy ≥12 weeks.
排除标准
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- •Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- •Known severe hypersensitivity to nab-paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with nab-paclitaxel doublet chemotherapy.
- •Prior treatment with paclitaxel.
- •Pregnant or lactating woman.
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- •Life expectancy of less than 12 weeks.
研究组 & 干预措施
Nab-paclitaxel single agent
Nab-paclitaxel single agent, either in 130mg/m2 weekly regimen, d1,8,15 every 4 weeks or in 230mg/m2 d1 every 3 weeks
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months
To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy
次要结局
- Progression free survival(24 months)
- overall survival(24 months)
- Side effects(24 months)
- Quality Of Life(24 months)
研究者
Caicun Zhou
Shanghai Pulmonary Hospital
Tongji University