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).
Conditions
Interventions
Amrubicin was given at 40mg/m2 intravenously over 5 minutes for three consecutive days, every 3 weeks
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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). Before study entry, at least 4 weeks must have elapsed since any prior chemotherapy or radiotherapy. Patients had to have measurable disease, a Eastern Cooporative Oncology Group (ECOG) performance status 0 or 1, and be aged between 20 and 74 years. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (according to RECIST criteria) | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed