non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion in stage4
Conditions
Interventions
Carboplatin/nab-paclitaxel+bevacizumab
Sponsors
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed Stage IV Non-small-cell lung cancer 2)Non-Squamous Non-small-cell lung cancer 3)Malignant pleural effusion requiring drainage 4)Adjuvant chemotherapy is permitted 5)At least one year has to be past since the last administration of adjuvant chemotherapy 6)Age : 20 years or older 7)At least one measurable lesion by RECIST 8)PS : 0-2 9)adequate major organ (hemoatologic hepatic, respiratory and renal function) function white blood cell >=3000/mm3 hemoglobin >=9.0g/dl platelet >=100000/mm3 total bilirubin <= 1.5 AST/ALT <=2.0 times upper limit of normal SpO2 >=90% Adequate organ function 10)Life expectancy more than three months 11)Adequate interval since the last radiation therapy or surgery 12)written informed consent
Exclusion criteria
Exclusion criteria: 1)History of pleurodesis or pleural effusion drainage 2)Severe infection except for non-active hepatitis C 3)Fever more than 38 degree 4)Severe comorbidity (heart failure/kidney failure/hepatic failure/uncontrollable diabetes/uncontrollable hypertension, etc) 5)Active double cancer 6)Symptomatic brain metastasis 7)History of hemoptysis with 2.5mL or more 8)Pericardial effusion requiring drainage 9)Interstitial pneumonia or pulmonary fibrosis detectable on X ray 10)History of drug sensitivity 11)Pregnant or lactating women 12)Psychiatric disease or mental trouble 13)Continuing administration of steroid 14)Evaluated to be ineligible by a physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Density of chest underwater VEGF before and after chemotherapy, overall survival time, safety, 1-year survival rate, progression free survival | — |
Countries
Japan
Contacts
Public ContactTamiya Motohiro
Osaka Prefectural Medical Center for Respiratory and Allergic diseases Thoracic Malignancy
Outcome results
None listed