non-small cell lung cancer
Conditions
Interventions
Addition of primary prophylaxis with pegfilgrastim to ramcirumab plus docetaxel treatment
Sponsors
Gunma University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically and/or cytologically proven non-small cell lung cancer 2.Patients who have previously treated with chemotherapy and have unresectable clinical stage IV or post-operative recurrence 3.Progression was observed during or after chemotherapy 4. More than twenty years old at the time of the agreement acquisition 5.ECOG Performace Status (PS) 0-1 6.Meets the following criteria absolute neutrophil: >=1500/mm3 platelet count: >=100,000/mm3 hemoglobin: >=10.0 g/dL AST and ALT: <=2.5 X ULN total bilirubin: <=ULN PT-INR: <=1.5 APTT: <=1.5 X ULN protein urea: <=1+ 7.Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of febrile neutropenia | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall Response Rate Disease Control Rate Overall Survival Safety, Toxicity | — |
Countries
Japan
Contacts
Public ContactNorimitsu Kasahara
Gunma University Department of Allergy and Respiratory Medicine
Outcome results
None listed