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).

Phase 2

Conditions: lung cancer
small cell lung cancer extensive disease
10038716

Registration Number: NL-OMON30640

Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

-Histologically/cytologically proven small cell lung cancer
-WHO performance status 0-2
-Measurable disease according to RECIST criteria
-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)
-Creatinine clearance: > 60 ml/min (Cockcroft and Gault)
-Adequate hepatobiliary function (ALAT/AST <2.5 x Upper Limit of Normal)
-Written informed consent before randomization, according to ICH/EU GCP and national/local regulations

Exclusion Criteria

-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)
-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
-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective tumor response, measured according to the RECIST criteria, will<br /><br>be used as the principal endpoint in this trial. Disease assessments will be<br /><br>preformed every 2 cycles. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety: This study will use the International Common Toxicity Criteria (CTCAE),<br /><br>version 3.0, for toxicity and adverse event reporting.<br /><br><br /><br>progression-free survival (PFS)<br /><br><br /><br>overall survival (OS). </p><br>