A phase II study of amrubicin for previously treated small cell lung cancer

UMIN ID: UMIN000001752

Registered date:05/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: For patients with recurrent small cell lung cancer
• Date of first enrollment: 2007/10/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Amrubicin is administered from day 1 to day 3.

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Safety, Overall survival, Progression-free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Pulmonary fibrosis detectable on chest X-ray films 2)Massive pleural effusion, ascites and pericardial effusion required drainage 3)Concomitant malignancy 4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome 5)Symptomatic brain metastasis 6)Pregnant or milk-feeding female. Intention to be pregnant in the future 7)With severe allergy 8)Other clinical difficulties to this study

Related Information

• Primary Sponsor: Gunma University Hospital
• Source(s) of Monetary Support: None