Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 90
- 主要终点
- Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling
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 capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.
详细描述
OBJECTIVES:
- Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study.
- Determine the anticancer efficacy of capecitabine, in terms of objective response rate (confirmed and unconfirmed, complete and partial responses) and 2-year survival, in these patients.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status of patients treated with this drug.
- Determine the clinical pharmacology of this drug in these patients.
- Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature.
OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs 18 to 59).
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 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
Capecitabine
Capecitabine 1,000 mg/m^2/dose (2,000 mg/m^2/day) BID, PO, Days 1-14 of 21 day cycle.
干预措施: capecitabine (Drug)
结局指标
主要结局
Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling
时间窗: Registration
次要结局
- Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival(2 years)
- Toxicity(3 years)
- Assess parameters of clinical pharmacology of capecitabine in patients aged 70 years or older including half life value(s), AUC (area under curve) and steady state levels(3 years)
- Assess whether patients under 60 years have clinical pharmacologic parameters similar to those reported in the literature(3 years)
- Explore, at a preliminary level, the feasibility of studying genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance to capecitabine(3 years)