A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer. - Phase II study of CBDCA+weekly PTX+Bev in chemo-naive patients with stage IIIB and IV non-sq, non-small cell lung cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
研究概览
简要总结
Aim: The present study aimed to evaluate the effectiveness and safety of weekly paclitaxel (PTX) combined with carboplatin (CBDCA) plus bevacizumab (BEV), followed by maintenance BEV in patients with advanced NSCLC. Patients and Methods: Patients with unresectable stage IIIB and IV NSCLC (n=43) were treated with CBDCA (AUC 6, day 1), BEV (15 mg/kg, day 1), and PTX (70 mg/m2, days 1, 8, 15) intravenously every 4 weeks, for 3 to 6 cycles, followed by maintenance BEV (15 mg/kg) every 3 weeks. Results: The objective response rate and disease control rate were 67.4% and 90.7%, respectively. The median progression-free survival was 7.6 months. The median overall survival was 17.7 months. Common adverse events were tolerable bone marrow suppression, fatigue, hypertension, and nasal bleeding. Conclusion: Weekly administration of PTX combined with CBDCA plus BEV therapy was effective, and well-tolerated by advanced NSCLC patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Uncontrolled infection or serious medical complications 2)massive,pleural effusion or ascites(accept controrable pleural effusion with OK-432) 3)current nervous symptom 4)severe cardiac disease 5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC 6)history of hemoptysis(over 1week) or receive oral/i.v. hemostatic drug 7)uncontrolled hypertension 8)Patients with active lung disease such as interstitial pneumonia,radiation pneumonitis,plumonary infection,or drug-induced lung damage 9)current or previous (within the last 1 year)history of GI perforation 10)history of myocardial infarction and cerebral infarction 11)history of drug allergy 12)active concomitant malignancy 13)pregnant or lactating women or those who declined contraception 14)those judged to be not suitable by the attending physician