Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000025972
- Lead Sponsor
- Gunma University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Symptomatic brain metastases 2. History of bleeding 3. Patient with HIV or HBV or HCV infection 4. Patient with active infection 5. Fever over 38 6. Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc) 6. Severe complication (congestive heart failure, arrhythmia, uncontrollable hyper tension, uncontrollable diabetes) 7.Interstitial pneumonia , fibroid lung confirmed by CT. 8.Patient with much ascetic fluid, pleural effusion, cardiac effusion. 9. Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ) 10. History of severe drug allergy 11.Patient with gastrointestinal perforation within 1 year. 12. Receiving anticoagulant therapy. (Aspirin 325mg or less to allow) 13. Patient thought as of high risk of bleeding (Obvious tumor invasion to main thoracic vessel and cavity) and of thromboembolizm. 14. History of docetaxel or ramcirumab treatment. 15. Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities. 16. Considered to be interfere to the agreement or understanding the protocol by attening doctor. 17. Patient with impaired mental status. 18. Pregnancy 19. Other ineligible status judged by attending doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method