Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
研究概览
简要总结
The goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied.
详细描述
Capecitabine, PK Testing, and DNA Analysis:
Capecitabine is designed to interfere with the growth of cancer cells, which may cause the cells to die. It is cleared from the body by certain proteins (which are made from DNA--the gene material of cells). Some patients have changes in these proteins that increase or decrease the rate that capecitabine is cleared from the body.
Researchers will use pharmacokinetic (PK) testing and DNA analysis to learn how capecitabine is cleared from your body. PK testing measures the amount of drug in the body at different time points. Information learned in this study may help researchers decide the best doses of capecitabine for future patients with breast cancer.
Screening Visit:
Before you can start treatment on this study, you will have about 2 teaspoons of blood drawn for routine tests and to make sure that you are able to receive chemotherapy. This screening blood test will help the study doctor decide if you are eligible to take part in this study.
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
- •Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the breast.
- •Patients must give informed consent for protocol participation.
- •Age >/= 18 years
- •Patients must have and ECOG performance status of </=
- •Patients must be scheduled to receive capecitabine using a BID dosing strategy administered on days 1-14 of a 21-day cycle.
- •Patients must agree to blood draws for PK/PD sampling.
- •Patients are allowed to receive cytotoxic therapy in combination with capecitabine.
- •Patients must not require concurrent radiation, or hormonal therapy while receiving protocol therapy
- •Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics as prophylaxis is allowed.
- •Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. Both men and women should practice an effective method of birth control while receiving capecitabine.
- •Patients must have recovered to grade <1 from all acute toxicity of previous chemotherapy, radiation or hormonal therapy and have adequate hematologic and hepatic function: Granulocyte count >/= 1,500/mcL; Platelet count >/= 100,000/mcL; Bilirubin </= 1.5 x ULN; AST and/or ALT </= 2 x ULN; Alkaline phosphatase (liver component, if fractionated) </= 2 x ULN; Serum creatinine within normal limits.
排除标准
- •Untreated or uncontrolled brain metastasis
- •History of prior therapy with capecitabine
- •Patient inability to take or absorb oral medications
研究组 & 干预措施
Capecitabine
Capecitabine - Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
时间窗: PK testing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose.
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
次要结局
未报告次要终点