PhaseII study of the efficacy of DOCETAXEL plus RAMUCIRUMAB for NSCLC with brain metastasis
- Conditions
- on-small cell lung carcinoma
- Registration Number
- JPRN-UMIN000024551
- Lead Sponsor
- Kyoto prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 25
Not provided
1. Patients who have never been received anticancer agents. 2. Patients who are currently receiving other anticancer therapy. 3. Patients who have symptomatic brain metastasis or patients who have undergone whole brain radiotherapy or surgical resection for brain metastasis. 4. Patients who have meningeal metastasis. 5. Patients who have either bleeding into the brain metastasis or other CNS hemorrhage on imaging performed within 21days before acquisition of consent. 6. Patients who have radiographic evidence of intratumor cavitation or major blood vessels invasion or encasement by cancer. 7. Patients who have experienced uncontrolled coagulation disorder (acquired or hereditary). 8. Patients who have experienced arterial thromboembolic events, deep vein thrombosis, serious bleeding complications or GI perforation/fistula within 6 months prior to acquisition of consent. 9. Patients who have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. 10. Patients who have a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to acquisition of consent. 11. Patients who have uncontrolled or poorly-controlled hypertension, metabolic disorder or clinically serious infection. 12. Patients who are pregnant, nursing or possibly pregnant. 13. The patient is receiving chronic antiplatelet therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival
- Secondary Outcome Measures
Name Time Method intracranial progression free survival overall survival disease control rate overall response rate safety