Phase II Study of Nab-paclitaxel and Carboplatin Plus Bevacizumab as First-Line Chemotherapy for Reccurent or stage IIIB and IV Nonsquamous Non-Small-Cell Lung Cancer (ALCT004)
- Conditions
- on-squamous non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000013310
- Lead Sponsor
- Kyorin University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Not provided
1)SVC synd 2)Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free 3)Severe active infection and sever complication (gastrointestinal hemorrhage,cardiac disease) 4)Pregnant status or lactation 5)Uncontrolled psychiatric disease 6)History of allergic reaction for agents of present treatment 7)Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 8)A history of significant hemoptysis (> 2.5 mL red blood per episode) before enrolment 9)Evidence of tumor invading large vessel on imaging, cavity and thrombus 10)History of thromboembolic events.Any history of cerebral, myocardial, and pulmonary infarction 11)Symptomatic brain metastasis 12)History of operation and biopsy within 4 weeks 13)Need to antiplatelet therapy or anticoagulation therapy without Aspirin 324 mg/day within 10 days 14)Bleeding tendency, blood coagulation disorder 15)Bowel obstruction 16)Current or previous history of gastrointestinal perforation and diverticulitis 17)Pulmonary fibrosis and interstitial pneumonia on chest X-ray or symptomatic pulmonary fibrosis and interstitial pneumonia 18)Uncontrolled hypertension and diabetes 19)Other ineligible status judged by medical oncologist
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method overall survival,progression free survival, safety,QO