Non-Squamous Non-Small-Cell Lung Cancer
Conditions
Interventions
Docetaxel(60mg/m2)day 1 +Bevacizumab (15mg/kg) day 1 The treatment is repeated every three weeks until disease progression or severe toxicity.
S-1: 40 mg/m2 twice daily(orally, day1 after dinner
day15 after breakfast)+ Bevacizumab: 15mg/kg day 1 The treatment is repeated every three weeks until disease progression or severe toxicity.
Sponsors
Hanshin Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Non-squamous 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 ->3 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 S-1 and docetaxel. 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 hypertension 9)uncontrollable diabetes mellitus 10)curative radiotherapy pretreated to the chest. 11)current history of hemosputum 12)current or previous history hemoptysis 13)current or previous (within the last 1 year) history of cerebrovascular disease 14)current or previous (within the last 1 year) history of GI perforation 15)symptomatic brain metastasis 16)traumatic fracture of unrecovery 17)the operation has been scheduled for the examination period 18)tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor 19)evidence of bleeding diathesis or coagulopathy 20)thrombosis that need to treat 21)severe drug allergy for 80 polysorbate content medicine 22)patients using Flucytosine 23)patients with contraindication of medication (DTX,S-1). 24)history of active double cancer 25)history of active psychological disease 26)history of pregnancy or lactation 27)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 ContactKazumi Nishino
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Pulmonary Oncology
Outcome results
None listed