NCT00812864已完成4 期
Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years)
University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL.
研究概览
简要总结
The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.
详细描述
Blood samples will be taken before 1rst course of chemotherapy of capécitabine for colorectal or breast metastatic cancer.
Pharmacokinetic will be realizes at several times (H0,5, H1, H1,5, H2, H4, H6, H8) and repeated at D14 of the 2d cycle
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
- Diagnostic
- 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
- •Elderly patients 75 years old or more
- •Life expectancy of greater then or equal to 6 months
- •Histologically proven metastatic breast or colorectal cancer, requiring a chemotherapy by capecitabine according to the habitual schema
- •Metastatic situation whatever treatment line
- •Previous hormonotherapy for breast cancer, prior chemotherapy (without capecitabine) in adjuvant and/or metastatic indication (colorectal or breast cancer), or radiotherapy (colorectal or breast cancer) are allowed
- •One or more measurable target lesion (RECIST criteria)
- •ADL>4 (geriatric scales)
- •GSD<12 (geriatric scales)
- •Laboratory values :
- •creatinine clearance (CrCl) >=30 mL/min according to Cockcroft formula
- •Adequate bone marrow function (neutrophils count > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin [Hb] > 10g/dl)
- •Adequate hepatic function: total bilirubin < 1,5 x upper normal limit, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 2,5x upper normal limits (in case of liver metastases < 5 x upper normal limits)
- •Alcalin phosphatases <=2,5x ULN (<=5 x ULN if liver metastases present).
- •Subjects must be willing to be followed during the course of treatment/observation and follow-up.
- •Signed written informed consent before first course of chemotheray
排除标准
- •Age < 75 years
- •known brain metastases
- •Concomitant oncologic treatment ongoing
- •History of severe or unscheduled reaction to fluoropyrimidine treatment
- •Prior unanticipated severe reaction to capecitabine or metabolites and to fluoropyrimidine therapy
- •Patient with leucopenia
- •sorivudine or chemical analogues treatment like brivudine
- •Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •Concomitant severe affections wich lead life expectancy inferior to 3 monthes
- •Uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure, coronarian spasmes
- •No possible oral administration
- •known DPD deficiency
- •Treatment with experimental therapy ongoing or within four weeks before inclusion.
- •Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the uterin cervix or basal or squamous cell carcinoma of the skin
研究组 & 干预措施
Capecitabine
Experimental
干预措施: Capecitabine (Drug)
结局指标
主要结局
Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL.
时间窗: 1 year
pharmacokinetics of capécitabine
次要结局
- Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum.(1 year)
- Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6.(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach AdenocarcinomaAdenocarcinoma of the StomachNCT00871273Cambridge University Hospitals NHS Foundation Trust13
已完成
4 期
Pharmacokinetic Study of Adjuvant Capecitabine After Resection of Pancreatic AdenocarcinomaPancreatic AdenocarcinomaNCT00854477Cambridge University Hospitals NHS Foundation Trust13
已完成
不适用
Capecitabine Pharmacokinetics(PK)-Actual Versus Ideal Body WeightNeoplasmsObesityNCT01828554University of Wisconsin, Madison8
尚未招募
不适用
A study of pharmacokinetic analysis of capecitabine and cytidine deaminase activityBreast and colorectal cancerJPRN-UMIN000019244Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital20
已完成
不适用
The Therapeutic Effect of Different Doses of CapecitabineCapecitabineNCT06246461Jingjiang People's Hospital150