non-small cell lung cancer
Conditions
Interventions
Weekly 60mg/ m2 (repetition of dose on 1st/8th day with 15th day rest) administration of amrubicin hydrochlorid
Sponsors
National Hospital Organization Nagoya Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven non-small cell lung cancer 2. Refractory to first- or second-line chemotherapy patients or relapsed patients 3. Age over 19 years 4. ECOG Performance Status of 0 to 2 5. With measurable lesion 6. Adequate main organ functions ( WBC >= 3000/uL, Neutrophils >= 1500/uL, Hb >= 9.0 g/dL, Platelets >= 100000/uL, AST and ALT <= two times upper normal limit, Total bilirubin <= 1.5mg/dL, Serum creatinine <= normal limit, SpO2 >= 90%, Left ventricular ejection fraction >= 60%) 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindication for amrubicin 2. Carcinomatous pleuritis, pericarditis, peritonitis and other metastasis 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 |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety, progression free survival, disease control rate two months later | — |
Countries
Japan
Contacts
Public ContactChiyoe Kitagawa
National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine
Outcome results
None listed