Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Establish the phase II recommended dose (P2RD) of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lung cancer.
研究概览
简要总结
The primary objective of the study is to establish the phase II recommended dose of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.
详细描述
Since the regimen of bevacizumab, carboplatin and paclitaxel has become a standard regimen for the treatment of advanced non-squamous NSCLC, new studies in this patient population will have to include this as a reference arm. Addition of a fourth anti-cancer agent has now become the new strategy to improve the outcome for advanced non-squamous NSCLC. Since the regimen of Vorinostat, Carboplatin and Paclitaxel is already in advanced stage of development it is important to study the safety and tolerability of Vorinostat in combination with the three-drug regimen of Bevacizumab, Carboplatin and Paclitaxel. Therefore, we will evaluate Vorinostat when administered in combination with the regimen of Carboplatin, Paclitaxel and Bevacizumab for patients with previously untreated advanced non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Advanced non-squamous NSCLC
- •No prior chemotherapy for advanced disease
- •ECOG performance status 0 or 1
- •Measurable disease
- •Life expectancy > 3 months
- •Normal bone marrow, renal and hepatic function
- •Ability to take oral medications
- •Willingness to sign informed consent
排除标准
- •History of brain metastasis
- •Evidence of thromboembolic phenomenon and treatment with anticoagulants
- •Pregnancy
- •Uncontrolled inter-current illness
- •Prior therapy with Paclitaxel
研究组 & 干预措施
1
Phase I dose escalating scheme
干预措施: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel (Drug)
2
Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.
干预措施: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel (Drug)
结局指标
主要结局
Establish the phase II recommended dose (P2RD) of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lung cancer.
时间窗: An average of 2 years
Participants will be followed for survival, an expected average of two years.
次要结局
- Evaluate safety profile of 4-drug regimen. Obtain preliminary evidence regarding anti-cancer activity of the regimen. Understand mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood and archived tumor tissue.(Average of 2 years)
研究者
Chandra P. Belani
Professor of Medicine
Milton S. Hershey Medical Center