Small Cell Lung Cancer
Conditions
Interventions
Patients receive amurubicin on days 1 and 8 every 3 weeks.
Sponsors
Central Japan Lung Study Group (CJLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven small cell lung cancer 2. Refractory to or relapsed after first-line platinum-containing chemotherapy, and fit for systemic chemotherapy 3. No prior use of amrubicin 4. Patients aged 20 or over 5. ECOG Performance Status of 0 to 2 6. With measurable lesion (RECIST 1.1) 7. Adequate main organ functions 8. Expected life expectancy of 3 months or more from the start of the treatment 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with contraindication for amrubicin 2. Patients with carcinomatous pleuritis, pericarditis, or peritonitis with the indication for local therapy 3. Patients during radiotherapy 4. Patients with symptomatic brain metastasis 5. Patients with SVC syndrome 6. Patients with cardiac dysfunction, myocardial infarction occurred within 6 months, uncontrolled angina pectoris, or uncontrolled cardiac failure 7. Patients with interstitial pneumonitis or pulmonary fibrosis on chest X-ray 8. Patients with uncontrolled diabetes mellitus 9. Patients who have been treated with limiting dose of anthracycline antitumor drug 10. Patients with active double cancer 11. Infected patients or possibly infected patients with a fever of 38 degrees Celsius or more 12. Pregnant or lactating woman 13. Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival: PFS Overall survival: OS Safety (Incidence of adverse events) | — |
Countries
Japan
Contacts
Public ContactHiroshige Yoshioka
Kurashiki Central Hospital Department of Respiratory Medicine
Outcome results
None listed