non-squamous non-small-cell lung cancer
Conditions
Interventions
Patients recieve Pemetrexed(500mg/m2 ,div), Carboplatin(AUC6 ,div), and Bevacizumab(15mg/kg ,div) on day1,every 3 weeks, up to 6 cycles. Patients who still control disease without unacceptable toxity,
Sponsors
Nippon Medical School Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)historogically or cytologically comfirmed non-squamous non-small-cell lung cancer 2) stageIIIB/IV(UICC-7) or postoperative recurrence non-squamous non-small-cell lung cancer 3)chemo-naive patients 4)age : 20-74 years old 5)ECOG performance status of 0 or 1 6)measurable by RECIST(ver 1.1) criteria 7)if the patient underwent therapy, there should be the following interval between the therapy and the registration 1. radiotherapy other than thoracic radiation >= 2 weeks 2.surgery >= 4 weeks 3.thoracic drainarge >= 2 weeks 4.open biopsy, CV-port reservation, and treatment of injury >= 2 weeks 5.aspiration biopsy >= 1week 8) adequate major organ(hematologic,hepatic,respiratory,and renal) function 1.neutrophil >= 1500mm3 2.platelet >= 100000mm3 3.hemoglobin >= 9.0g/dL 4.AST/ALT <= 2.5 times upper limit of normal 5.total bilirubin <= 1.5 times upper limit of normal 6.predicted creatinin clearance or 24-h creatinine clearance >= 45mL/min 7.SpO >= 93% 8.urine protein <= 1+ or <= 2g/day 9)life expectancy more than 3 months 10)written informed consent
Exclusion criteria
Exclusion criteria: 1)Uncontrolled infection or serious medical complications 2)massive pleural effusion or ascites(accept controrable pleural effusion with OK-432) 3)brain metastasis 4)history of severe cardiac disease 5)uncontrollable diabetes 6)recieving anticoagulant drug(except Aspirin under 324mg/day) 7)history of gross hemoptysis(>2.6ml) 8)history of severe hemosputum(over 1week, or reciving hemostatic drug) 9)uncontrollable hypertension 10)history of GI perfortion(within the last 1 year) 11)history of myocardial infarction or cerebral infarction 12)interstitial pneumonia or pulmonary fibrosis detectable on CT scan 13)history of drug-indused pneumonitis 14)the operation has been scheduled for the examination period 15)treatment history of Pemetrexed, Carboplatin, and Bevacizumab 16)severe drug allegy 17)not reciving folic acid and vitamin B12 18)active concomitant malignancy 19)history of severe mental disorder 20)now pregnant or lactation 21)judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate, feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| safety,progression free survival,time to response,overall survival | — |
Countries
Japan
Contacts
Public ContactKazuhiro Kitamura
Nippon Medical School Department of Internal Medicine, Division of Pulmonary Medicine, Infectious Diseases, and Oncology
Outcome results
None listed