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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the activity and safety of amrubicin alone versus amrubicin in combination with cisplatin versus standard treatment for extensive disease ED small-cell lung cancer in the first line setting.;Secondary Objective: Secondary endpoints will include toxicity of treatment including cardiotoxicity ,progression-free survival PFS and overall survival OS . These endpoints will be reported in a descriptive way.;Primary end point(s): The primary endpoint of the study is the overall response rate.

Secondary Outcome Measures

Name	Time	Method

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