Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 99
- 试验地点
- 25
- 主要终点
- Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
研究概览
简要总结
The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically/cytologically proven small cell lung cancer
- •Extensive disease
- •Measurable disease
- •World Health Organization (WHO) performance status 0-2
- •Age 18 years or older
- •Normal baseline cardiac function
- •No prior systemic chemotherapy for small cell lung cancer
- •Adequate organ function including bone marrow, kidney, and liver
- •No history of interstitial lung disease or pulmonary fibrosis
- •No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
- •No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception
- •Written informed consent before randomization
- •Exclusion criteria:
- •Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0)
- •Uncontrolled or severe cardiovascular disease
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
排除标准
- 未提供
研究组 & 干预措施
Amrubicin
Amrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
干预措施: Amrubicin (Drug)
Amrubicin plus Cisplatin
Amrubicin 40mg/m<2> IV days 1, 2, 3 plus cisplatin 60mg/m<2> IV day 1 of each 21-day cycle until disease progression.
干预措施: Amrubicin (Drug)
Amrubicin plus Cisplatin
Amrubicin 40mg/m<2> IV days 1, 2, 3 plus cisplatin 60mg/m<2> IV day 1 of each 21-day cycle until disease progression.
干预措施: Cisplatin (Drug)
Cisplatin plus etoposide
Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 each 21-day cycle until disease progression.
干预措施: Cisplatin (Drug)
Cisplatin plus etoposide
Cisplatin 75mg/m<2> IV day 1 plus etoposide 100mg/m<2> IV day 1 and 200mg/m<2> orally days 2, 3 or etoposide 100mg/m<2> IV days 1, 2, 3 each 21-day cycle until disease progression.
干预措施: Etoposide (Drug)
结局指标
主要结局
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
时间窗: Until Disease Progression
次要结局
- Toxicity(Until 30 days after last protocol treatment)
- Overall survival(Until death)
- Progression-free survival(Until disease progression or death)