non-small cell lung cancer
Conditions
Interventions
Bevacizumab, Paclitaxel, Carboplatin
Sponsors
North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology 2) No prior chemotherapy 3) 70 years or older 4) ECOG-PS 0 or 1 5) At least one or more measurable lesion by RECIST. 6) Adequate organ function 7) Interval -Palliative radiotherapy >2wks -Surgery >4wks -thoracic drainage>1wks -biopsy with dissection, indwelling port >1wks -blood transfusion >1wks 8) Life expectancy more than three months. 9) Written Informed Consent
Exclusion criteria
Exclusion criteria: 1) History of hemoptysis 2) High risk of bleeding or thrombus events 3) History of anticoagulant within 10 days before enrollment 4) Grade 2 or worse neuropathy 5) Uncontrollable hypertension 6) Symptomatic brain metastasis 7) Uncontrollable pleural effusion or peritoneal effusion 8) Scheduled operation 9) Severe complications 10) Severe infection 11) History of active double cancer 12) No intention to birth control 13) Unstable psychic disorder 14) History of treatment drug 15) History of severe allergic reaction with platinum drug or monoclonal antibody 16) History of allergic reaction with taxan drug, polyoxyethylene or alcohol. 17) Decision of ineligibility by a physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Disease control rate, Progression free survival, Overall survival, Biomarker analysis, correlation of efficacy with EGFR gene mutation | — |
Countries
Japan
Contacts
Public ContactSatoru Miura
Niigata University Medical & Dental Hospital Division of Respiratory Medicine
Outcome results
None listed