lung cancer
Conditions
Interventions
Weekly (repetition of dose on 1st/8th day with 15th day rest) administration of amrubicin hydrochloride
Sponsors
Central Japan Lung Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven lung cancer 2. Refractory to first- or second-line chemotherapy patients or relapsed patients 3. Age over 19, and less than 80 4. Performance Status (ECOG): 0 to 2 5. Adequate main organ functions WBC>=4000/uL Neutro>=2000/uL Hgb>=9.0 g/dL Platelets>=100000/uL AST, ALT: less than two times the upper normal limit T. Bil <=1.5 mg/dL s-Cr: less than upper normal limit SpO2 >= 90% Left ventricular ejection fraction >=60% 6. Postoperative recurrence and asymptomatic brain metastasis 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindication for amrubicin 2. Carcinomatous pleuritis, pericarditis, pritonitis with local therapy indication 3. Patient can not enroll during radiotherapy, but can be registered after interval (chest: four weeks; without chest: one weeks). 4. Serious medical complication: Uncontrolled angina pectoris, myocardial infarction for less than 3 months; patient with cardiac failure. Uncontrolled diabetes mellitus, hypertension. 5. Infected patients 6. Other clinical difficulties in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety Pharmacokinetic study at the first cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate in assessable patients | — |
Countries
Japan
Contacts
Public ContactChiyoe Kitagawa
National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine
Outcome results
None listed