A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum (Per 04/99 Amendment) Old Title: A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum Confined to the Liver
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 21
- 主要终点
- response rate
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with liver metastases from colorectal cancer.
详细描述
OBJECTIVES: I. Evaluate the efficacy of treatment with oxaliplatin, fluorouracil, and leucovorin calcium in terms of the resectability rate in patients with unresectable advanced colorectal carcinoma confined to the liver. II. Assess this regimen in terms of response rate, toxicity, and overall survival in these patients.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
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
oxaliplatin + leucovorin + fluorouracil
Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
干预措施: fluorouracil (Drug)
oxaliplatin + leucovorin + fluorouracil
Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
干预措施: leucovorin calcium (Drug)
oxaliplatin + leucovorin + fluorouracil
Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable. Patients who achieve complete response (CR), partial response (PR) with unresectable disease, or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a response are treated until best response or until disease is deemed resectable. Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
干预措施: oxaliplatin (Drug)
结局指标
主要结局
response rate
时间窗: Up to 4 years
次要结局
- overall survival(Up to 4 years)