A Phase I Dose-Escalating Study of Induction Gemcitabine/Pemetrexed Followed by Pemetrexed and Concurrent Upper Abdominal Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy
研究概览
简要总结
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with radiation therapy in treating patients with locally advanced pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of pemetrexed disodium when given in combination with upper abdominal radiotherapy after induction therapy comprising gemcitabine hydrochloride and pemetrexed disodium followed by consolidation therapy with gemcitabine hydrochloride in patients with locally advanced pancreatic cancer.
- Determine the quantitative toxicity of this regimen in these patients.
Secondary
- Determine the quantitative and qualitative dose-limiting toxicities of pemetrexed disodium in combination with upper abdominal radiation therapy.
- Evaluate patterns of failure, response, and survival of these patients at 1 year
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 120 Years（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
Pemetrexed in combination with concomitant radiotherapy
Patients will receive Pemetrexed plus Radiotherapy.
干预措施: pemetrexed disodium (Drug)
Pemetrexed in combination with concomitant radiotherapy
Patients will receive Pemetrexed plus Radiotherapy.
干预措施: Radiotherapy (Device)
结局指标
主要结局
Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy
时间窗: 42 days
Quantitative Toxicity of Pemetrexed When Administered With Concomitant Radiation Therapy
时间窗: 42 days
次要结局
- Patterns of Failure(1 year)
- Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy(42 days)
- Patterns of Response(1 year)
- Number of Participants That Survived(1 year)