Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Three-month Progression-free Survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.
详细描述
Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC
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
- •Pathologically/histologically confirmed NSCLC
- •Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)
- •Measurable disease
- •Two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy
- •Prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy)
- •ECOG performance status 0, 1, or 2
- •Patients with brain metastases are allowed, if clinically stable after treatment
- •Normal liver, kidney, and marrow function
- •18 years of age or older
- •Negative pregnancy test for women of child-bearing potential.
- •Life expectancy 3 months or more
- •No concurrent use of other antitumor agents
排除标准
- •Prior therapy with vorinostat, HDAC inhibitors, or bortezomib
- •Pre-existing neuropathy grade >/= 2
- •Myocardial infarction within 6 months prior to enrollment or have NY Heart Association Class III or Class IV heart failure
- •Have taken valproic acid </= 4 weeks prior to enrollment
- •Previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- •Hypersensitivity to bortezomib, boron, or mannitol
- •Serious medical or psychiatric illness likely to interfere with participation in the clinical study
- •Pregnant women
- •HIV positive patients
- •Hepatitis infection (HCV or HBV) patients
研究组 & 干预措施
Vorinostat + Bortezomib
Vorinostat 400 mg + Bortezomib 1.3 mg/m2
干预措施: vorinostat (Drug)
Vorinostat + Bortezomib
Vorinostat 400 mg + Bortezomib 1.3 mg/m2
干预措施: bortezomib (Drug)
结局指标
主要结局
Three-month Progression-free Survival
时间窗: Three-months post-treatment
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."
次要结局
- Toxicity(30 days post-treatment)
- Response Rate(Until disease progression, up to 2 years)
- Median Overall Survival(5 years)