Previously treated non-small cell lung cancer
Conditions
Interventions
Amrubicin hydrochloride is given at previously decided dose intraveniously for three consecutive days every 3 weeks.
Sponsors
Keio University School of Medicine Division of Pulmonary Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients had histologically or cytologically confirmed stage IIIB/IV NSCLC, with failure of prior chemotherapy (two regimen). Before study entry, at least 4 weeks must have elapsed since any prior chemotherapy or radiotherapy. Patients had to have measurable disease, a Eastern Cooperative Oncology Group (ECOG) performance status 0 ,1 or 2, 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, or severe infection. Patients who have already received amrubicin and other anthracycline drugs were excluded, too.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I;To verify MTD and RD Phase II; primary endpoint: disease control rate, response rate secondary endpoint: overall survival(OS), progression free survival (PFS),safety | — |
Countries
Japan
Outcome results
None listed