A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
- Conditions
- on-squamous non-small cell lung cancer (EGFR mutation status Negative)
- Registration Number
- JPRN-UMIN000005991
- Lead Sponsor
- Toho University Omori Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Not provided
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan. 2)Patients with active co-morbidities including severe conditions. 1.uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease. 2.uncontrollable diabetes, hypertension. 3.severe infection 4.paresis of intestine, illeus 5.Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum 6.Great vessel involvement 7.Melena 8.Receiving anticoagulant drug 9.Uncontrolled urinari protein 10.CongenitalbleedingdiathesisCoagulation abnormalities 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor. 3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated. 4) Brain metastases with neurological symptoms. 5) Active double cancer. 6)Pregnancy, breast feeding and suspected pregnancy. 7)History of grave drug allergic reaction. 8) Psychiatric disorder. 9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RR: Response rate
- Secondary Outcome Measures
Name Time Method QOL: Quality of life DCR: Disease control rate PFS: Progression free Survival OS: Overall survival AE: Adverse events