Non-Small-Cell Lung Cancer
Conditions
Interventions
nab-paclitaxel(100mg/ m2 day1,8) Gemciabine (1000mg/ m2 day1, 8) The treatment is repeated every three weeks until disease progression or severe toxicity.
Sponsors
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer 2)non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery,who have previously treated platinum doublet. 3)With measurable lesion(RECIST version 1.1) 4)at an interval of more than four weeks from previous treatment 5)If the patient underwent therapy, there should be the following interval between the therapy and the registration i)Radiotherapy other than thoracic radiation ->1 week ii)Palliative radiotherapy including pulmonary field ->2 months iii)Surgery(except CV-port reservation) ->4 weeks iv)Thoracic drainarge ->2 weeks v)Open biopsy, treatment of injury ->2 weeks vi)Aspiration biopsy, CV-port reservation ->1 week 6)Age-> 20 7)ECOG PS 0-1 8)Adequate organ function 9)Life expectancy more than 3 months 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)history of drug induced interstitial pneumonia 3)history of severe drug allergy 4)patients previously treated with paclitaxel, gembcitabine, nab-paclitaxel. 5)history of active infection or other serious disease condition 6)history of poorly controlled pleural effusion,pericardial effusion and ascites 7)history of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,heart failure, etc.) 8)uncontrollable diabetes mellitus 9)curative radiotherapy pretreated to the chest. 10)current neuropathy >Grade2 11)history of active double cancer 12)history of active psychological disease 13)history of pregnancy or lactation 14)any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Overall survival Disease control rate Rate of adverse events | — |
Countries
Japan
Contacts
Public ContactMOTOKO TACHIHARA
Kobe University Graduate School of Medicine Division of Respiratory Medicine, Department of Internal Medicine
Outcome results
None listed