NCT00303745Unknown2 期
Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer
Federation Francophone de Cancerologie Digestive46 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 78
- 试验地点
- 46
- 主要终点
- Objective response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.
PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the objective response or stable disease rate in elderly patients with unresectable, progressive, metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine.
Secondary
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- •Unresectable disease
- •Documented progressive disease during first-line/palliative chemotherapy
- •Measurable disease ≥ 1 cm that is outside prior radiation field
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy ≥ 3 months
- •No contraindication to chemotherapy
- •Creatinine clearance ≥ 40 mL/min
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement)
- •Bilirubin ≤ 1.5 times normal
- •Transaminases ≤ 5 times normal
- •No symptomatic coronary disease or cardiac insufficiency
- •No enteropathy or chronic diarrhea
- •No unresolved intestinal occlusion or subocclusion
- •No history of severe unexpected reaction to a fluoropyrimidine
- •No other active malignancy in the past 2 years
- •No hypersensitivity to irinotecan hydrochloride or its excipients
- •No hypersensitivity to capecitabine or fluorouracil
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior extensive resection
- •No concurrent sorivudine or similar analogs (e.g., brivudine)
- •No other concurrent anticancer therapy
- •Concurrent radiotherapy allowed for nontarget lesions
排除标准
- 未提供
结局指标
主要结局
Objective response
Stable disease rate
次要结局
- Tolerability
- Quality of life
- Progression-free and overall survival
研究者
研究点 (46)
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