Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy

UMIN ID: C000000071

Registered date:22/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: All patients had histologocally or cytologically confirmed locally advanced (non-irradiated) or metastatic NSCLC, with failure of platinum-based chemotherapy (exception for UFT and gefitinib).
• Date of first enrollment: 2005/02/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Amrubicin was given at 40mg/m2 intravenously over 5 minutes for three consecutive days, every 3 weeks

Outcome(s)

• Primary Outcome: Overall response rate (according to RECIST criteria)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion, pericardial effusion, or ascites, pregnancy, lactation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, severe superior vena cava syndrome, uncontrollable diabetes mellitus, severe infection, or active peptic ulcer. Patients who have prior receive amrubicin and other anthracycline drugs were excluded, too.

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None