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 - ND

CABRELLIS PHARMACEUTICALS CORPORATIO0 个研究点目标入组 85 人开始时间: 2007年3月23日最近更新: 2012年3月19日

研究概览

暂无简介。

•Histologically/cytologically proven small cell lung cancer Extensive stage as defined by Harris et al. WHO performance status 0-2 Measurable disease RECIST Age / 18 years Normal baseline cardiac function. Adequate haematological function WBC 1.5 x 10 9 /L, platelets 100 x 10 9 /L, Hb 9 g/dL and Creatinine clearance 60ml/min Cockroft and Gault Adequate hepatobiliary function ALT/AST 2.5 x Upper Limit of Normal No prior systemic chemotherapy for small cell lung cancer 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 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

•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 Ref. 39 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 Pregnancy or breast feeding. Men and Women of child bearing potential must use an appropriate method of contraception if the risk of conception exists

发起方

CABRELLIS PHARMACEUTICALS CORPORATIO