Phase 2 study of amrubicin plus bevacizumab in patients with previously treated advanced non-sq NSCLC
- Conditions
- on small cell lung cancer
- Registration Number
- JPRN-UMIN000013350
- Lead Sponsor
- Gunma University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1. Symptomatic brain metastases 2. History of bleeding 3. Patient with active infection 4. Fever over 38 5. Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc) 6. Obvious interstitial pneumonia , fibroid lung confirmed by CT. 7.Patient with much ascetic fluid, pleural effusion, cardiac effusion. 8. Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ) 9. History of severe drug allergy 10.Patient with gastrointestinal perforation within 1 year. 11. Patient thought as of high risk of bleeding (Obvious tumor invasion to main thoracic vessel and cavity) and of thromboembolizm. 12. Receiving anticoagulant therapy. (Aspirin 325mg or less to allow) 13. History of amurubicin treatment, or other anthracycline treatment within upper limit cardiac toloreated dose(daunorubicin: 25mg/kgdoxorubicin: 500mg/m2, Epilbicine: 900mg/m2: pirarubicin: 900mg/m2, etc) 14. Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities. 15. Considered to be interfere to the agreement or understanding the protocol by attening doctor. 16. Patient with impaired mental status. 17. Pregnancy 18. Other ineligible status judged by attending doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall Response Rate Disease Control Rate Overall Survival Safety, Toxicity