Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.
详细描述
This phase I trial will escalate doses of the histone deacetylase inhibitor (HDAC) vorinostat to a chemoradiation platform for cisplatin, pemetrexed and radiation to a dose of 70Gy in NSCLC patients with unresectable IIIA and dry IIIB disease. The endpoint will be to determine MTD of the combination.
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
- •biopsy proven non-squamous NSCLC with unresectable stage IIIA or dry IIIB disease.
- •FEV1 >/= 1 liter
- •ECOG PS 0 or 1
- •Able to swallow and absorb enterally
- •Measurable disease per RECIST 1.1
- •Adequate organ and marrow function including calculated creatinine clearance >/= 60 mL/min hepatic enzymes and alk phos </= 2.5 X ULN.
排除标准
- •Chemotherapy or radiotherapy </= 4 weeks prior to registration (6 weeks for nitrosureas)
- •Active bleeding
- •Known brain mets
- •Prior thoracic radiotherapy that would lead to overlap with current radiation field.
- •More than 10% weight loss in 6 months.
- •Pancoast tumors, supraclavicular or contralateral hilar lymph node involvement
- •Known HIV positive
- •Prior treatment with an HDAC inhibitor
研究组 & 干预措施
vorinostat
Dose escalation of vorinostat, cisplatin, pemetrexed and radiation
干预措施: vorinostat (Drug)
结局指标
主要结局
To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.
时间窗: toxicity assessments will occur weekly
次要结局
- To investigate progression free survival.(CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression)
- To evaluate response rates with this combination(CT/PET will be done following 12 weeks of therapy.)
- To assess if pre-treatment tumor expression of TS, ERCC1 and HDAC1, 2, 3 are associated with response rate.(Archival tissue will be tested and correlated to response rates.)