Non-Squamous Non-Small Cell Lung Cancer
Conditions
Interventions
To continue chemotherapy with Bevacizumab plus Pemetrexed until the onset of ecxacerbation or intolerable adverse event.
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)>=20years-old 2)StageIIIB/IV unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC. 3)Documented disease progression after bevacizumab plus a platinum-based chemotherapy 4)Life expectancy>=3months 5)Eastern Cooperative Oncology Group(ECOG)Performance Status0,1 6)Measurable lesion meeting RECIST criteria(version1.1) 7)Adequate organ function neutrophil count:>=2,000/mm3or<=13,000/mm3 Platelet count:>=100,000/mm3 Hemoglobin:>=9.5g/dl AST,ALT<=2.5*upper limit of normal Total bilirubin:<=1.5mg/dl creatinine:<=1.5mg/dl PT-INR:<=1.5 Urinary protein negative or 1+ PaO2>=90% 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Prior Pemetrexed treatment 2)History of hemoptysis(>=2.5ml) 3)History of severe drug allergy 4)Thrombosis 5)Active infection 6)Any other serious complication (severe heart disease, perforation of the digestive tract, uncontrollable diabetes or hypertension, gastrointestinal hemorrhage, paresis of intestine, illeus, interstinal lung disease etc.) 7)Prior radiotherapy to the chest or the more than 20% region of bone with hematopoietic capacity 8)Massive pleural or pericardial effusion, ascites *include patients if there is no accumulation within two weeks after dranage tube was removed. *exclude patients if pleurosclerosis was performed with anti-cancer drugs except OK-432 9)Inadequate interval after prior treatments *operation including exploratory or diagnostic thoracotomy within 4 weeks *palliative radiotherapy within 2 weeks *biopsy with incision and treatment for trauma (exclude patiente with unhealed wound) within 2 weeks *transfusion or use of hematopoietic factor within 2weeks. 10)Concomitant malignancy 11)Severe psychotic disorder 12)Pregnancy,Lactation,declined contraception 13)Inappropriate for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, progression- free survival, overall survival, Time from the initination of previous treatment to the progression of disease after the treatment with this protocol, frequency of adverse events. | — |
Countries
Japan
Contacts
Public ContactMasaharu Shinkai
Yokohama City University Medical Center Respiratory Disease Center
Outcome results
None listed