Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed non-small cell lung cancer 2)unresectable disease 3)The presence of measureable lesions 4)Age of 20 years or older 5)Life expectancy more than 12weeks 6)ECOG Perfomance status 0-2 7) Previous 1-2 regimen chemotherapy consisting of platinum 8)oral UFT for adjuvant chemotherapy do not count as 1 regimen 9)EGFR-TKI or ALK inhibiter do not count as 1 regimen 10)Interval of more than 28 days from the last chemotherapy or radiotherapy 11)preserved organ's function WBC>=3,000/mm3 Hemoglobin>= 9.0g/dl Platelet count>=100,000/mm3 Total serum bilirubin <=1.5 mg/dl GOT/GPT <100 IU/l Serum creatinine <=1.5mg/dl 12)Acquisition of written informed consent
Exclusion criteria
Exclusion criteria: 1)patients previously treated with paclitaxel derivative drugs 2)Anamnesis of hypersensitivity to albumin 3)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case) 4)evident pericardial effusion 5)serious complications below uncontrollable angina pectoris, myocardial infarction within 3 months or heart failure uncontrollable diabetes uncontrollable hypertension severe infection 6)pulmonary fibrosis or interstitial pneumonitis evident 7)HB and HC virus carrier 8)now pregnant or lactation 9)difficult to perform or continue of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, frequency of adverse events | — |
Countries
Japan
Contacts
Kanagawa Cancer Center Department of Thoracic Oncology