A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 5
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 DX-8951f in treating patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy.
详细描述
OBJECTIVES: I. Determine the objective response rate in patients with metastatic carcinoma of the exocrine pancreas treated with DX-8951f. II. Determine the time to tumor progression in patients receiving this drug. III. Determine the survival at 6 and 12 months of patients receiving this drug. IV. Evaluate the quantitative and qualitative toxicities of this regimen in this patient population. V. Evaluate the pharmacokinetics of this drug in this patient population.
OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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