A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 14
- 主要终点
- Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients.
OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
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
R115777
300mg/dose BID, PO, Days 1-21, q 28days
干预措施: R115777 (Drug)
结局指标
主要结局
Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777
时间窗: 6 months
次要结局
- Time to treatment failure(Once every 8 weeks until progression)
- Evaluate the frequency and severity of toxicities(Weekly for 8 weeks and then once every 4 weeks)
- Assess confirmed response (complete & partial) in patients with measurable advanced adenocarcinoma of the pancreas(Once every 8 weeks)