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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 97

Inclusion Criteria

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
No radiotherapy for SCLC within 14 days before treatment
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 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The primary endpoint of the study is the overall response rate.<br><br> ;<br> Secondary Objective: Secondary endpoints will include toxicity of treatment (including cardiotoxicity),<br> progression-free survival (PFS) and overall survival (OS). These endpoints will be reported in a<br> descriptive way.<br> ;<br> Primary end point(s): Primary end point is overall response rate.<br><br>

Secondary Outcome Measures

Name	Time	Method

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