A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 18
- 主要终点
- Maximum tolerated dose
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in treating patients who have cancer of the pancreas or stomach.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and cisplatin that can be administered during a standard course of radiation therapy for patients with unresectable or locally recurrent pancreatic and gastric cancer. II. Describe the tolerance of gemcitabine, cisplatin, and radiation therapy in this patient population. III. Seek preliminary evidence of the therapeutic activity of this regimen in this patient population as measured by survival.
OUTLINE: This is a dose escalation study. Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly on Tuesday and Friday over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. The dose limiting toxicity (DLT) is defined as the dose at which at least 2 of 6 patients experience unacceptable toxic effects. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next 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 —（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
radiation + gemcitabine + cisplatin
Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year.
干预措施: cisplatin (Drug)
radiation + gemcitabine + cisplatin
Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year.
干预措施: gemcitabine hydrochloride (Drug)
radiation + gemcitabine + cisplatin
Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Maximum tolerated dose
时间窗: Up to 3 years
次要结局
- Survival(Up to 3 years)