ISRCTN68146831已完成2 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
Cardiff University (UK)0 个研究点目标入组 82 人开始时间: 2009年7月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
研究概览
简要总结
2016 Abstract results in https://dx.doi.org/10.1200/jco.2016.34.2_suppl.448 results (added 16/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female
- •2. Aged greater than or equal to 16 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 (Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), 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:
- •4.1. Creatinine clearance less than 60 ml/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 less than 30 ml/min)
- •4.2. Eastern Cooperative Oncology Group (ECOG) performance status 2. N.B. patients are excluded if PS is 3 or worse.
- •4.3. Clinically significant ischaemic heart disease (myocardial infarction [MI] or unstable angina 3 - 12 months prior to date of randomisation, or symptomatic angina 0 - 3 months prior to date of randomisation). N.B. See section 4 of exclusion criteria.
- •4.4. Prior intolerance of cisplatin
- •4.5. Aged greater than 75 years
- •4.6. Any other factor, which, in the opinion of the investigator indicates that cisplatin is not suitable for this patient
- •5. The patient has provided written informed consent
排除标准
- •1. Laboratory results rendering the patient unsuitable for trial treatment:
- •1.1. Serum bilirubin greater than 1.5 x the upper limit of reference range (ULRR)
- •1.2. Creatinine clearance less than or equal to 30 ml/min (calculated by Cockcroft-Gault formula)
- •1.3. Potassium, less than 4.0 mmol/L despite supplementation; or above the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 1 upper limit
- •1.4. Magnesium below the normal range despite supplementation, or above the NCI CTCAE grade 1 upper limit
- •1.5. Serum calcium above the NCI 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.
- •1.6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times ULRR or alkaline phosphatase (ALP) greater than 2.5 x ULRR, or greater than 5 times 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. PS (ECOG) 3 or worse
- •4. Clinically significant cardiovascular event (e.g., myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease greater than or equal to 2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (NCI 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 first degree relative with unexplained sudden death under 40 years of age
- •7. Presence of left bundle branch block (LBBB)
- •8. QTc with Bazett's correction that is unmeasurable, or greater than or equal 480 msec on screening electrocardiogram (ECG). (Note: If a subject has a QTc interval greater than or equal to 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 less than 480 msec in order for the subject to be eligible for the study.) Patients who are receiving a drug that has a risk of QTc prolongation are excluded if QTc is greater than or equal to 460 msec.
- •9. Concomitant medication which has known adverse interaction with vandetanib, including:
- •9.1. Any medication that may cause QTc prolongation or induce Torsades de Pointes
- •9.2. Potent inducers of CYP3A4 function (e.g. rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort)
- •10. Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater tha
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