The utility of genomics and functional imaging to predict Irinotecan pharmacokinetics and pharmacodynamics: The PREDICT Irinotecan Study

Peter MacCallum Cancer Centre0 个研究点目标入组 70 人开始时间: 2010年10月21日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Histologically/cytologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma not amenable to surgery or radiation therapy with curative intent, eligible for first-line or second-line chemotherapy with Irinotecan-5FU (FOLFIRI regimen or FOLFIRI-Bevacizumab [Avastin]); measurable or evaluable disease, adequate hepatic, bone marrow and renal function, Eastern Cooperative Oncology Group (ECOG) 2 or less, life expectancy greater than 12 weeks, written informed consent for the study and its associated procedures.

•Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol or compromises the patient's ability to give informed consent.
•Female patients who are pregnant or breast-feeding.
•Any unresolved toxicity greater than NCI-CTC Grade 2 from previous anti-cancer therapy, active liver disease (e.g. chronic active hepatitis, cirrhosis), known diagnosis of human immunodeficiency virus (HIV) infection or Gilbert’s syndrome, prior severe reaction of fluoropyrimidine therapy, known sensitivity to 5-FU or deficit of dihydropyrimidine-dehydrogenase (DPD)

发起方

Peter MacCallum Cancer Centre