pfront Sunitinib (SU011248)® therapy followed by surgery in patients with metastatic renal cancer: a pilot Phase II study [SuMR] - SuMR

Queen Mary University London0 个研究点目标入组 40 人开始时间: 2007年3月9日最近更新: 2017年8月21日

研究概览

暂无简介。

•1.Histopathologically confirmed renal cell carcinoma (clear cell) with measurable metastases on CT/ imaging.Patients with suspicion of renal cancer on radiology must have a biopsy to confirm diagnosis of clear cell, taken as part of the study.
•2.Judged by the treating physician to have the potential to derive clinical benefit form sunitinib treatment
•3.Male or Female, 18 years of age or older
•4.Adequate organ function as defined by the following criteria:
•Total serum bilirubin =2 x ULN (patients with Gilbert’s disease exempt)
•Serum transaminases <5 x ULN
•Serum creatinine =2 x ULN
•Absolute neutrophil count (ANC) =1000/mm3 without growth factor support
•Platelets = 75,000/mm3
•5.Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment.
•6.Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
•7.ECOG performance status of 0,1 or 2.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable arrhythmia requiring medication.
•2.Previous treatment for renal cancer.
•3.Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use adequate contraception during the period of therapy. The definition of effective contraception will be based on the judgement of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use adequate contraception.
•5.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormally that would impart, in the judgement of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study

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