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

Not Applicable
Conditions
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).
Registration Number
JPRN-C000000071
Lead Sponsor
West Japan Oncology Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall response rate (according to RECIST criteria)
Secondary Outcome Measures
NameTimeMethod
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