Phase II study evaluating the efficacy and safety of the Bevacizumab / Docetaxel maintenance therapy beyond stable disease in patients with advanced relapsed non-squamous NSCLC who received Bevacizumab / pemetrexed / platinum induction therapy
- Conditions
- advanced relapsed non-squamous NSCLC
- Registration Number
- JPRN-UMIN000010055
- Lead Sponsor
- Respiratory Center, Showa University Northern Yokohama Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Patients with symptomatic brain metastases. 2. Patients with history or complication of hemoptysis. *Definition of hemoptysis is determined by the following. A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine. 3. Patients with a history of severe drug allergy. 4. Patients with uncontrolled ascites, pleural effusion, or pericardial effusion 5. Patients with a history of gastrointestinal perforation within an year, or a complication of uncontrollable peptic ulcer. 6. Patients with uncontrolled hypertension 7. Patients with infectious disease requiring systemic administration of antiviral agents, antifungal agents, or antibiotics. 8. Patients receiving anticoagulant therapy 9. Patients receiving antiplatelet therapy *Patients receiving aspirin therapy up to 325mg are allowed to be registered. 10. Patients with a history of radiation to the chest, or more than 20% region of bones with hematopoietic ability 11. Patients with multiple cancers within 5years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer. 12. Patients with serious complications (such as heart disease, active infection, interstitial pneumonia, diabetes) 13. Pregnant woman or those with suspected pregnancy, nursing woman and those who plan to become pregnant during the study period. 14. Other patients whom the investigation considers to be unsuitable for participation in the study. 15. Patients treated with EGFR-TKI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method