Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer.
- Conditions
- on-small and non-squamous cell lung cancer
- Registration Number
- JPRN-UMIN000012450
- Lead Sponsor
- Department of Respiratory Medicine National Center for Global health and Medicine-Hospital
- Brief Summary
Because of slow accrual, this study will not be capable of completion. The study committee decided termination of this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Not provided
1)Patients with squamous cell lung cancer. 2)History of allergic reaction for agents of present treatment 3)Severe myelosupperssion, renal dysfunction or hepatic dysfunction 4)Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free 5)Active infection more than and equal to grade 2 6)Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 7)Patients required for continuing more than and equal to 10 mg/day of steroid therapy 8)A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment 9)History of thromboembolic events 10)Any history of cerebral, myocardial, and pulmonary infarction 11)Bleeding tendency, blood coagulation disorder 12)Other ineligible for bevacizumab 13)Pregnant status or lactation 14)Uncontrolled psychiatric disease 15)Other ineligible status judged by medical oncologist.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) from the beginning of maintenance therapy
- Secondary Outcome Measures
Name Time Method Response rate (RR) by RECIST, Disease control rate (DCR), Overall survival (OS), Time to treatment failure (TTF), maintenance rate, PFS from the start of induction therapy, Adverse events,