non-squamous non-small cell lung cancer
Conditions
Interventions
Patients receive CBDCA(AUC6,i.v.), Pemetrexed(500mg/m2,i.v.) and Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, up to six cycles.Patients who achieved disease control(response or stable disease
Sponsors
Kansai Medical University Hirakata Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) 2)Stage IIIB/IV(UICC-7) or postoperative recurrence NSCLC 3)cheno-naive patient(except oral 5-FU) 4)Age:20 years to less than 75 years. 5)ECOG performance status of 0 or 1 6)Measurable by RECST(ver 1.1) criteria. 7)Patient who has the following periods. palliative radiotherapy(ex thorax):2 weeks operation:4 weeks chest drainage:2 weeks Biopsy with incision, port custody, and treatment to injury:2 weeks Aspiration biopsy cytology:1 week 8)adequate bone marrow, liver, and renal functions neutro > 1,500/mm-3 Plt > 100,000/mm-3 Hb > 9.0 g/dL-1 neutro > 2,000 mm-3 AST(GOT), ALT(GPT)< 2.5x upper normal limit T-Bil< 1.5x upper normal limit creatinine clearance > 45 ml/min SpO2> 93% Urinari protein <= 1+ or 2g/24hrs 9)a life expectancy of 3 months or more 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)current or previous treated brain metastasis 4)severe cardiac disease 5)uncontrolled diabetes mellitus 6)receiving anticoagulant drug(except Aspirin under 325mg/day) 7)current or previous history of hemoptysis(>=2.5ML) due to NSCLC 8)history of hemoptysis(over 1 week) or receive oral/i.v. hemostatic drug 9)uncontrolled hyper tension 10)current or previous (within the last 1 year) history of GI perforation 11)interstitial pneumonia or lung fibrosis evident on CT 12)history of drug induced interstitial pneumonia 13)Patient who has been scheduling operation for examination period 14)treatment history of carboplatin, pemetrexed and bevacizumab 15)severe drug allergy 16)Patient who cannot or doesn't hope administer multivitamin and vitamin B12 17)active concomitant malignancy 18)severe psychological disease 19)pregnant or lactating women or those who declined contraception 20)those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival Overall Survival Time to Response Safety | — |
Countries
Japan
Contacts
Public ContactTakashi Yokoi
Kansai Medical University Hirakata Hospital respiratory medicine
Outcome results
None listed