previously treated small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Histologically or cytologically proven small-cell lung cancer 2 Age between 20 and 75 years 3 Have measurable lesions as defined by RECIST 4 Confirmation of progressive disease, refractory disease, or relapse after first chemotherapy(both limited and extensive stage) 5 Prior one more chemotherapeutic regimen 6 At least 4 weeks must have elapsed since radiotherapy 7 Adequate organ functions Neutrophil count>=1500/mm3 Platelet count>=100,000/mm3 Hemoglobin>=9.0g/dl Serum creatinine<=1.5mg/dl Serum bilirubin<=1.5mg/dl AST/ALT<=100mg/dl 8 ECG: no abnormality needed therapy 9 Performance status(ECOG)0-2 10 Life expectancy more than 12 weeks 11 Written informed consent
Exclusion criteria
Exclusion criteria: 1 severe pleural, pericardial effusion, ascites or supra vena cava syndrome 2 sever complication(severe cardiac disease, heart failure, myocardial infarction and angina pectoris within the last 6 months, cerebrovascular disease within the last 6 months, poorly controlled hypertension, active infection)and another active cancer 3 symptomatic brain metastases 4 pregnancy, intent to became pregnant,or breast-feeding 5 active psychological disease 6 non eligible cases judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival median survival time Safety(incidence of adverse event) | — |
Countries
Japan
Contacts
Nagoya University Graduate School of Medicine respiratory medicine