EUCTR2006-001956-11-NL进行中（未招募）不适用
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
Cabrellis Pharmaceuticals Corporation0 个研究点目标入组 85 人开始时间: 2007年8月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically/cytologically proven small cell lung cancer Extensive disease as defined by Davis et al
- •WHO performance status 0-2
- •Measurable disease according to RECIST criteria (imaging within 28 days prior to entry)
- •Age = 18 years
- •Normal baseline cardiac function
- •No prior systemic chemotherapy for small cell lung cancer
- •Adequate haematological function (WBC >1.5 x 10 9 /L, platelets >100 x 10 9 /L, Hb> 9 g/dL)
- •Creatinine clearance: = 60ml/min (Cockroft and Gault)
- •Adequate hepatobiliary function (ALT/AST <2.5 x Upper Limit of Normal)
- •All the blood tests should be performed within 14 days of patient inclusion.
- •No history of interstitial lung disease or pulmonary fibrosis
- •No history of prior malignancy unless patient has been disease free for >5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
- •Absence of pre-existing peripheral neuropathy (CTCAE version 3.0 grade >1)
- •Absence of uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinical significant pericardial disease or cardiac amyloidosis.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •No pregnancy or breast feeding. Men and Women of child bearing potential must use an appropriate method of contraception if the risk of conception exists
- •Written informed consent before randomization, according to ICH/EU GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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