EUCTR2011-003553-26-DE进行中（未招募）不适用
A single arm study in metastatic colorectal cancer patients treated with pharmacokinetically (PK) dose adjusted weekly or biweekly 5-fluorouracil (5-FU) regimes. - C-5FU-TDM
CESAR Central European Society for Anticancer Drug Research-EWIV0 个研究点开始时间: 2012年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1)Capable of understanding the protocol requirements and risks, and providing written informed consent.
- •(2)Patients with histologically confirmed metastatic colorectal cancer.
- •(3)ECOG Performance Status (ECOG-PS) status = 2.
- •(4)Female or male patients of 18 years of age or older
- •(5)Life expectancy > 3 months
- •(6)Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (intrauterine device [IUD], oral contraceptive or double barrier method of contraception), and must have a negative serum pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active male patients must also use acceptable contraceptive methods (condom).
- •(7)An absolute neutrophil count >1.5/nl
- •(8)Platelet count > 100/nl.
- •(9)Total bilirubin = 2 x upper limit of normal.
- •(10) AST and ALT = 2.5 x upper limit of normal, or = 5 x upper limit of normal in case of liver metastases.
- •(11)Serum creatinine = 2x upper limit of normal
- •(12)Hemoglobin = 9 g/dl (may be corrected by transfusion prior to 5-FU treatment with investigator approval).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •(1)Symptomatic brain metastasis.
- •(2)Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study.
- •(3)Unwilling or unable to follow protocol requirements or to give informed consent.
- •(4)Any treatment with cytotoxic or biologic agents within the 4weeks prior to beginning treatment on this study. At least 4 weeks must have elapsed from any prior surgery or radiation.
- •(5)Unresolved toxicity from prior chemotherapy (including approved and experimental drugs) greater than grade I.
- •(6) Known Dihydropyrimidine dehydrogenase (DPD) deficiency
研究者
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