NCT00702884已完成2 期
A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers
Tony Bekaii-Saab1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression-free Survival Rate
研究概览
简要总结
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory esophageal or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- To determine the progression-free survival rate (complete response, partial response, and stable disease as defined by RECIST criteria [Response Evaluation Criteria in solid Tumors]) at 24 weeks in patients with relapsed or refractory esophageal or gastroesophageal junction cancer treated with sunitinib malate.
Secondary
- To explore the predictive role of a hybrid imaging protocol that combines PET/CT (Positron emission tomography) scan simultaneously with dynamic contrast-enhanced MRI.
- Correlate quantitative changes in mean vessel density, alterations in tumor cell proliferation, and apoptosis in tumor biopsy specimens with clinical outcome in these patients.
- To evaluate the objective response as defined by RECIST criteria, median overall survival, and median progression-free survival of these patients.
- To evaluate the toxicities of sunitinib malate in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sunitinib
Experimental
Sunitinib 37.5 mg daily for a 4 week cycle
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Progression-free Survival Rate
时间窗: up to 24 weeks
Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks
次要结局
- Frequency and Severity of Adverse Events(up to 4 years)
- Overall Response Rate(up to 4 years)
- Median Overall Survival Time(up to 4 years)
- Median Progression-free Survival Time(up to 4 years)
- Change in Mean Vessel Density(up to 4 years)
- Quantitative Assessment of Proliferating Tumor Cells and Apoptosis(up to 4 years)
研究者
Tony Bekaii-Saab
Principal Investigator
Ohio State University Comprehensive Cancer Center
研究点 (1)
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