Non-Small Cell Lung Cancer Non-Squamous cell lung cancer
Conditions
Interventions
Level 1 bevacizumab 15mg/kg and amrubicin (25mg/m2) Level 2 bevacizumab 15mg/kg and amrubicin (30mg/m2) Level 3 bevacizumab 15mg/kg and amrubicin (35mg/m2) Level 4 bevacizumab 15mg/kg and amrub
Sponsors
National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histology/cytology-proven non-squamous non-small cell lung cancer 2)Stage IIIB, IV and unsuitable for radiotherapy 3)With one or more measurable disease based on RECIST 4)Previously treated with platinum-based chemotherapy as a first line treatment 5)Performance status(ECOG): 0-1 6)Age<75 7)Adequate organ function 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Squamous cell carcinoma 2)Discontinued bevacizumab due to its toxicity during a first line treatment 3)Serious infections/with fever 4)Serious clinical problems 5)Interstitial pneumonia/lung fibrosis on chest X-ray 6)History or complication of hemoptysis with 2.5ml per time or more 7)Continuous bloody phlegm more than 1 week or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent. 8)Tumor cavitation 9)Uncontrollable hypertension 10)History of GI perforation 11)Previous treatment with amrubicin 12)Massive pericardial, pleural effusion, ascites 13)Active concomitant malignancy 14)Symptomatic brain metastasis 15)Previous drug allergy 16)Those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) of amrubicin and bevacizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti tumor efficacy | — |
Countries
Japan
Contacts
Public ContactMasao Ichiki
National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Outcome results
None listed