A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed Plus Bevacizumab in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.
- Conditions
- on-squamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000003770
- Lead Sponsor
- Osaka Lung Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1) squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Pleural effusion, pericardial effusion and ascites to need treatment 4) Patients unable to take or unsupplied with folic acid and vitamin B12 5) Severe renal function disorder 6) SVC syndrome 7) Brain metastases with neurological symptoms 8) Active double cancer 9) Uncontrollable diabetes mellitus and hypertenson 10) Liver cirrhosis by image findings or laboratory examinations 11) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.) 12) Pregnancy, breast feeding and suspected pregnancy 13) History of grave drug allergic reaction 14) Acute inflammatory disease 15) An agreement is not obtained for support therapy such as transfusion etc 16) Having the bleeding tendency which is clinically apparent 17) 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 PFS: progression free survival OS: overall survival DCR: disease control rate AE: Adverse events