Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301) - Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
ung Cancer 2016, in press Results: Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7 % (90% confidence interval, 19.3% to 44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4 to 7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0 to 18.0 months) months. The median number of treatment cycles was four (range, 1 to 17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%. Conclusion: Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.
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) Anamnesis of hypersensitivity to paclitaxel or albumin 2) Treatment history of taxanes (recurrence after more than one year from adjuvant chemotherapy including taxanes is permitted.) 3) Patient received chemotherapy within 4 weeks or EGFR-TKI within 2 weeks. 4) Patient received curative radiotherapy within 6 weeks or regional palliative radiotherapy within 2weeks. 5) Patient received operation within 4 weeks or surgical open within 2 weeks. 6) Symptomatic brain metastasis 7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment. 8) Active infectious disease in need of systemic administration of anti-bacterial drugs 9) Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on) 10) Patient needed to be administered with immunosuppressive drugs such as azathioprine , cyclophosphamide , methotrexate , or steroid 11) Active double cancer within 5 years of disease free interval (but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer ,by endoscopic mucosal resection , curative cutaneous cancer except for malignant melanoma ) 12) Peripheral neuropathy Grade2 or over 13) Pregnancy or lactating patients , or no intention to practice birth control. 14) Uncontrolled psychiatric disease 15) Physician judged improper to entry this trial