Association of Capecitabine Pharmacokinetics and Toxicity With Aging
A Prospective Evaluation of Capecitabine and Metabolite Pharmacokinetics in Elderly Breast and Colorectal Cancer Patients and Their Association With Toxicity and Molecular Markers of Enzyme Activity and Aging
研究概览
研究类型
注册 (预期的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1) Histologic or cytologic diagnosis of breast cancer or colorectal cancer. Patients should have disease that is suitable for capecitabine monotherapy as defined by the NICE Guidelines.
2) Patients must be within the first week of their first cycle of capecitabine treatment.
3) Estimated life expectancy of greater than 3 months. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5) Total serum bilirubin less than or equal to 25 micromol/L. 6) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2.5 times the upper limit of the normal range.
7) Serum albumin level greater than 32 g/L. 8) Creatinine clearance greater than or equal to 30 mL/minute. 9) Blood haemoglobin level of greater than 9 g/dL, with transfusion allowed. 10) Absolute neutrophil count greater than 2.5 x 109/L. 11) Platelet count greater than 100 x 109/L. 12) 18 years of age or older. 13) Written informed consent.
Exclusion Criteria:
- Pregnancy or breast feeding.
- Known HIV, Hepatitis B, or Hepatitis C infection.
- Known Gilbert syndrome.
- Uncontrolled diabetes (HbA1c greater than 7.5%).
Any condition or disease that might affect oral absorption of medications, including:
- Crohn's disease
- Ulcerative colitis
Major gastric or small bowel resection
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学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：卡培他滨
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area under the curve (AUC) of capecitabine and metabolites
大体时间：0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose
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Measurement of AUC of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.
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0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Toxicities and grades as scaled by Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03
大体时间：Six months
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Toxicity grade(s) as measured by CTCAE version 4.03 (published by the U.S. Department of Heath and Human Services 2009).
General grading scheme is as follows: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4: Life-threatening consequences; urgent intervention indicated.
Grade 5: Death related to AE.
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Six months
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Progression free survival as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
大体时间：From time of enrollment until first documented progression
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Progression free survival as measured by the RECIST criteria version 1.1 (Eisenhauer et al., 2009).
The RECIST criteria define progression as 'at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Note: the appearance of one or more new lesions is also considered progression)'
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From time of enrollment until first documented progression
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Response as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
大体时间：From time of enrollment to first documented response
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Complete or partial response as measured by the RECIST criteria version 1.1. (Eisenhauer et al., 2009) Complete response = 'Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response = 'At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.' |
From time of enrollment to first documented response
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Grip strength measured in kg
大体时间：During 6-hour pharmacokinetic study session
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Grip strength measured in kg by the grip strength test (using the Takei handheld dynamometer)
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During 6-hour pharmacokinetic study session
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Frailty as measured by the Edmonton Frail Scale
大体时间：During 6-hour pharmacokinetic study session
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Frailty as measured by the Edmonton Frail Scale.
A 17 point scale that measures 9 frailty domains.
0-5: not frail; 6-7: vulnerable; 8-9: mild frailty; 10-11: moderate frailty; 12-17: severe frailty.
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During 6-hour pharmacokinetic study session
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Nutritional status as measured by the Mini Nutritional Assessment questionnaire
大体时间：During 6-hour pharmacokinetic study session
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Nutritional status as measured by the Mini Nutritional Assessment questionnaire, a 30 point test on nutritional status. Scoring: 24 to 30 points: Normal nutritional status. 17 to 23.5 points: At risk of malnutrition. Less than 17 points: malnourished. |
During 6-hour pharmacokinetic study session
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Quality of life as assessed by the European Organization for Research and Treatment of Cancer quality of life (EORTC-QLQ-C30 version 3) questionnaire
大体时间：During 6-hour pharmacokinetic study session
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Quality of life as measured by the EORTC-QLQ-C30 version 3 questionnaire.
This questionnaire assesses the quality of life of cancer patients in a series of 30 questions, with 28 of the questions on a scale of 1 to 4 where 1 is 'not at all' and 4 is 'very much'.
Final two questions relate to overall quality of life and health on a scale of 1 to 7, where 1 is 'very poor' and 7 is 'excellent'.
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During 6-hour pharmacokinetic study session
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Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay)
大体时间：0 hours post dose (pre-dose)
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Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay).
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0 hours post dose (pre-dose)
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Maximum plasma concentration (Cmax) of capecitabine and metabolites
大体时间：0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose
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Cmax of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.
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0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose
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Time of maximum plasma concentration (Tmax) of capecitabine and metabolites
大体时间：0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose
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Cmax of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.
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0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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卡培他滨的临床试验
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AstraZenecaSWOG Clinical Trials Partnerships; Daiichi Sankyo招聘中乳腺癌美国, 中国, 丹麦, 英国, 大韩民国, 加拿大, 德国, 意大利, 比利时, 西班牙, 日本, 法国, 台湾, 希腊, 巴西, 瑞典, 波多黎各
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AstraZenecaDaiichi Sankyo招聘中乳腺癌西班牙, 中国, 美国, 意大利, 英国, 大韩民国, 比利时, 法国, 德国, 日本, 越南, 加拿大, 巴西, 印度, 马来西亚, 台湾, 澳大利亚, 奥地利, 泰国, 火鸡, 香港, 波兰, 瑞士, 保加利亚, 匈牙利, 新加坡