Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy
- 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
Not provided
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
Name Time Method Overall response rate (according to RECIST criteria)
- Secondary Outcome Measures
Name Time Method