EUCTR2009-010140-33-GB进行中（未招募）1 期
A randomised phase II Trial of carboplatin and gemcitabine +/- vandetanib in first line treatment Of advanced Urothelial cell Cancer in patients who are not suitable to receive cisplatin - Vandetanib in non-cisplatin fit patients with urothelial cancers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
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
入选标准
- •Patients meeting all of the following criteria may be included in the trial:
- •1.Male or female
- •2.Age greater than or equal to 18 years
- •3.Histologically confirmed transitional cell carcinoma (pure or mixed histology) of urothelium (upper or lower urinary tract). Cancers with other pathologies are permitted, provided that the dominant morphology is transitional cell carcinoma.
- •4.Radiologically measurable (RECIST 1.1), locally advanced/and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy not suitable for cisplatin, defined as one or more of the following:
- •a)Creatinine clearance <60ml/min estimated by Cockcroft and Gault formula or measured by 24-hour urine collection or isotope clearance (N.B. patients are excluded if creatinine clearance is <30ml/min)
- •b)ECOG Performance Status 2 (note patients are excluded if PS is 3 or worse)
- •c)Clinically significant ischemic heart disease (MI or unstable angina 3-12 months prior to date of randomisation, or symptomatic angina, New York Heart Association Class I, 0-3 months prior to date of randomisation). See section 4 of exclusion criteria.
- •d)Prior intolerance of cisplatin
- •e)Age greater than 75
- •f)Any other factor, which, in the opinion of the investigator indicates that cisplatin is not suitable for this patient (e.g. unilateral hearing loss)
- •5.The patient has provided written informed consent.
- •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 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 82
排除标准
- •If any of the following criteria apply, patients cannot be included in the trial:
- •1.Laboratory results rendering patient unsuitable for trial treatment:
- •a)Serum bilirubin >1.5x the upper limit of reference range (ULRR)
- •b)Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula or measured by 24-hour urine collection or isotope clearance).
- •c)Potassium, <4.0 mmol/L despite supplementation; or above the CTCAE grade 1 upper limit
- •d)Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit
- •e)Serum calcium above the CTCAE grade 1 upper limit. In cases where the serum calcium is below the normal range, the calcium adjusted for albumin is to be obtained and substituted for the measured serum value. Exclusion is to then be based on the adjusted for albumin values falling below the normal limit.
- •f)Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULRR or alkaline phosphatase (ALP) >2.5 x ULRR, or > 5x ULRR if judged by the investigator to be related to liver metastases
- •2.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 trial or which would jeopardize compliance with the protocol
- •3.ECOG performance status = 3.
- •4.Significant risk of cardiac complications defined as any of the following:
- •a)Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the investigator, significantly increases the risk of ventricular arrhythmia (N.B. this is complementary to inclusion criterion 4 (above)).
- •b)History of arrhythmia (multifocal premature ventricular contractions PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not exclusionary
- •5.QTc prolongation with other medications that required discontinuation of that medication
- •6.Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age
- •7.Presence of left bundle branch block (LBBB)
- •8.QTc that is unmeasurable or > 480 msec on screening ECG. (Note: If a subject has a QTc interval >480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study.) Patients who are receiving a drug that has a risk of Torsades de Pointes are excluded if QTc is = 460 msec. Note: the method for estimating QTc must be consistent between all time points for any individual patient.
- •9.Concomitant medication which has known adverse interaction with vandetanib, including:
- •a)Any medication that may induce Torsades de Pointes (TdP). Note some medications that induce TdP may be continued with additional ECG monitoring
研究者
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