advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) non-squamous, non-small cell lung cancer 2) Age over twenty 3) Idiopathic interstitial pneumonia 4) Measurable lesion 5) expected treatment date to be 4 weeks over surgury, 2 weeks over drainage of pleural effusion, 2 weeks over biopsy requiring incision, 1 week over bronchoscopic procedure or implantation of central venous port 6) ECOG performance status 0 or 1 7) Adequate organ function WBC>=3000/mm3 and neutrophil count >=2000/mm3 Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, urine protein<= 1+ 8) PaO2>=60.0 torr or SpO2>=92.0 %( room air) 9) Life expectancy > 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Secondary interstitial pneumonia. 2) History of acute exacerbation of interstitial pneumonia within 3 months. 3) Subacute progression of interstitial pneumonia within 3 months. 4) Using prednisolone or immune-suppressive agent. 5) In need of home oxygen therapy. 6) Past history of severe drug allergy. 7) Active infectious disease. 8) Severe complications 9) brain metastasis. 10) Uncontrollable effusion. 11) history of hemosputum 12) tumor invasion into thoracic large vessels or tumor with cavity 13)active gastrointestinal ulcer 14)bleeding tendency 15)operation wound not cured 16)thrombosis in need with treatment 17) Active combined malignancy 18) Any ineligible case judged by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| OS: overall survival PFS: progression free survival TTF: time to treatment failure toxicity | — |
Countries
Japan
Contacts
Kobe City Medical Center General Hospital Department of Respiratory Medicine