advanced non-squamous non-small-cell lung cancer
Conditions
Interventions
Carboplatin AUC5+pemetrexed 500mg/m2, day1, 21-day cycle, four cycles. After four cycles of the therapy, patients who achieved more than stable disease receive maintenance therapy with pemetrexed 500m
Sponsors
Hamamatsu Univ. School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. pathologically or cytologically diagnosed non-squamous non-small-cell lung cancer. 2. measurable disease in RECIST. 3. ECOG PS of 0-1 4. Stage IIIB without indication of curative radiotherapy, stage IV disease or recurrence disease without prior adjuvant chemotherapy. 5. Aged 76 years or older. 6. adequate organ function. Neutrophil cout of more than 2000/uL Platelet cout of more than 100000/uL Hemoglobin level of more than 9.0 g/dL Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range. PaO2 of more than 60 torr or SpO2 of more than 90%. Serum creatinine of less than 1.2mg/dL or creatinine clearance of less than 45mL/min. Protein urea less than plus 1 in urine test. 7: Life expectancy of more than 3 months. 8: Written informed consent.
Exclusion criteria
Exclusion criteria: 1. squamous histology 2. interstitial lung disease or pulmonary fibrosis 3. presence or history of hemoptysis 4. pleural effusion or cardiac effusion that needs to be treated 5. superior vena cava syndrome 6. uncontrolled and symptomatic brain metastasis except stable brain metastases after radiotherapy 7. uncontrolled diabetes, hypertension, liver damage, ischemic heart disease or myocardial infarction within three months. 8. severe infectious disease 9 pregnancy, lactation, or willing to get pregnant. 10. active malignancy of other organ. 11.history of severe hypersensitivity to drugs 12. bleeding diathesis or coagulopathy 13. symptomatic cerebrovascular disease, or history of brain attack 12 months prior to the study. 14. uncontrolled digestive ulcer or history of gastrointestinal perforation. 15. other severe comorbidities 16. judgement of discontinuation by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, overall survival, safety, quality of life(QoL) | — |
Countries
Japan
Contacts
Public ContactMasato Karayama
Hamamatsu Univ. School of Medicine Department of Internal medicine, second division.
Outcome results
None listed