A Phase II Trial of Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer After Failure of Platinum Doublet (Except Pemetrexed) Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.
详细描述
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. A multicenter randomized controled trial (coded as CA031) showed that nab-paclitaxel in combination with carboplatin had higher response rate than traditional paclitaxel plus carboplatin, especially in squamous lung cancer. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer after failure of platinum-based doublet therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed-consent form;
- •Age no less than 18 years;
- •Histologically confirmed locally advanced or metastatic squamous lung cancer;
- •Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks;
- •RECIST measurable lesions;
- •Disease progression after failure of platinum-based doublet therapy;
- •Adequate liver/renal/bone marrow function;
- •Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end;
- •Compliance, and can be followed up regularly.
排除标准
- •Pregnant or breast-feeding female, or not willing to take contraception measures during study;
- •Radiotherapy within 30 days, systematic therapy within 21 days;
- •Serious infection requiring antibiotics intervention during recruitment;
- •Allergic to study drug;
- •Require concurrent biological target therapy;
- •More than grade 1 neuropathy;
- •Uncontrolled brain metastasis or mental illness;
- •Congestive heart failure, uncontrolled cardiac arrhythmia, etc;
- •Other malignancy within 5 years;
- •Can't be followed up or obey protocol;
- •Ineligible by the judge of the investigator.
研究组 & 干预措施
nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
干预措施: nanoparticle albumin-bound paclitaxel (Drug)
结局指标
主要结局
Objective response rate
时间窗: up to one year
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
次要结局
- Quality of life(up to 15 months)
- progression-free survival(up to 15 months)
- Overall survival(up to 2 years)
- Safety and tolerability(up to 18 months)
研究者
LI Junling
Professor and chief physician
Chinese Academy of Medical Sciences