Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Toxicity profile of yttrium Y 90
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Capecitabine may also make tumor cells more sensitive to radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass microspheres when given together with capecitabine in treating patients with liver cholangiocarcinoma or liver metastases.
详细描述
OBJECTIVES:
- Establish the maximally tolerated dose of yttrium Y 90 glass microspheres in combination with capecitabine in patients with intrahepatic cholangiocarcinoma or liver metastases.
- Characterize the toxicity of this regimen in these patients.
- Determine the time to tumor progression in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also receive yttrium Y 90 glass microspheres by intra-arterial hepatic infusion on days 1-7 of course 2.
After completion of study therapy, patients are followed every 3 months for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Cohort 1 (capecitabine, Y90)
2,000mg/m2 capecitabine +110 Y90
干预措施: capecitabine (Drug)
Cohort 1 (capecitabine, Y90)
2,000mg/m2 capecitabine +110 Y90
干预措施: yttrium Y 90 glass microspheres (Radiation)
Cohort 2 (capecitabine , Y90)
2,000mg/m2 capecitabine + 130 Y90
干预措施: capecitabine (Drug)
Cohort 2 (capecitabine , Y90)
2,000mg/m2 capecitabine + 130 Y90
干预措施: yttrium Y 90 glass microspheres (Radiation)
Cohort 3 (capecitabine, Y90)
2,000mg/m2 Capecitabine + 150 Y90
干预措施: capecitabine (Drug)
Cohort 3 (capecitabine, Y90)
2,000mg/m2 Capecitabine + 150 Y90
干预措施: yttrium Y 90 glass microspheres (Radiation)
Cohort 4 (capecitabine, Y90)
2,000 mg/m2 capecitabine = 170 Y90
干预措施: capecitabine (Drug)
Cohort 4 (capecitabine, Y90)
2,000 mg/m2 capecitabine = 170 Y90
干预措施: yttrium Y 90 glass microspheres (Radiation)
结局指标
主要结局
Toxicity profile of yttrium Y 90
时间窗: During treatment and up to 30 days post-treatment
Toxicity will be defined as number of adverse events related to treatment experienced during treatment
Time to tumor progression
时间窗: At time of disease progression
Maximal tolerated dose of yttrium Y 90
时间窗: During treatment and any time up to 6 weeks post-treatment
次要结局
未报告次要终点
研究者
Mary Mulcahy
Principal Investigator
Northwestern University