A Phase II Trial of Sorafenib and Erlotinib in Unresectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Number of Patients With Progression-free Survival
研究概览
简要总结
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of sorafenib tosylate in combination with erlotinib hydrochloride in patients with unresectable pancreatic cancer.
Secondary
- To determine the response rate in patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen at 4 months.
- To evaluate the safety profile of this regimen in these patients.
- To evaluate the change in serum Ca 19-9 levels at baseline and at 8-week intervals.
- To evaluate the plasma proteomic profile at baseline and at 8 weeks to correlate with clinical parameters in order to identify potential prognostic or predictive markers.
- To analyze single-nucleotide polymorphisms on DNA obtained from pretreatment blood samples to evaluate toxicity and response to erlotinib hydrochloride.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
Sorafenib + Erlotinib
干预措施: Sorafenib (Drug)
Treatment
Sorafenib + Erlotinib
干预措施: Erlotinb (Drug)
结局指标
主要结局
Number of Patients With Progression-free Survival
时间窗: at 8 weeks
Number of patients with progression-free survival at 8 weeks
次要结局
- Response Rate(at 4 months)
- Number of Patients With Progression-free Survival(at 4 months)
- Number of Patients With Worst Grade Toxicities(every 4 weeks and every 8 weeks in follow-up to resolution of toxicity)
研究者
Jordan Berlin, MD
Professor of Medicine; Clinical Director, GI Oncology Program; Director, Phase I Program; Medical Director, Clinical Trials Shared Resources; Medical Oncologist
Vanderbilt-Ingram Cancer Center