A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000004715
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1) Prior treatment with docetaxel 2) Have central nervous system metastases (A patient who has previously treated brain metastases, without evidence of progression or hemorrhage at baseline is eligible) 3) Currently have or have a history of hemoptysis (>= one-half teaspoon of bright red blood per event) 4) Clinically significant drug allergy 5) Have a evidence of thrombosis 6) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide 7) Have a history of serious systemic disease including: clinically significant cardiovascular disease; medically uncontrolled diabetes and hypertension; gastrointestinal perforation, gastroparesis, or obstruction 8) Uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management) Regarding the patient who have or have had pleural effusion; a) A patients who developed recurrent effusion within two weeks after drainage tube removal is ineligible b) A patient who received intrapleural chemotherapy (excluding BRM such as OK432) for pleurodesis is ineligible 9) Patients with or with anticipation of invasive procedures as defined below: a) Major surgery within four weeks of registration b) Palliative radiotherapy within two weeks of registration c) Minor surgical procedures, core biopsy or traumatic injury, within two weeks of registration d) Transfusion of any blood products within two weeks of registration 10) Have another active malignancy 11) Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray 12) Mental disease or psychotic manifestation 13) Pregnant or beeast-feeding woman or patient who doesn't agree to contraception 14) Not suitable for participating in the study for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method