NL-OMON30640Not yet recruitingPhase 2
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). - amrubicin, amrubicin-cisplatin versus etoposide-cisplatin in SCLC
European Organisation for Research in Treatment of Cancer (EORTC)0 sites14 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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