CISPLATIN PLUS PACLITAXEL IN ADVANCED CARCINOMA OF THE UROTHELIUM

作为单一的化疗药物，顺铂和紫杉醇已被证明对尿路上皮移行细胞癌具有临床应用价值。因此，这项第二阶段的研究将检查这两种药物在这些受试者中的组合。主要目的是评估顺铂和紫杉醇的联合抗肿瘤活性，通过总体应答率来衡量。总体存活率和毒性也将进行评估。将采用两阶段抽样设计，最大有效值为51名患者。紫杉醇将在每21天周期的第一天以175 mg/m2的剂量在3个小时内静脉注射。顺铂将在每21天周期的第一天通过顺铂以75 mg/m2的剂量在30-120分钟内通过自由流动的静脉输注给药。此外，由于移行细胞癌细胞细胞核中P53的积聚已被证明是疾病复发和死亡的统计显著预测指标，独立于肿瘤分级、分期和淋巴结状况，研究人员将检测肿瘤石蜡切片中的P53水平。

As single chemotherapeutic agents, cisplatin and paclitaxel have each been shown to have clinical utility in transitional-cell cancer of the urothelium. This phase-II study will therefore examine the two agents in combination in these subjects. The primary objective is to evaluate the combination of cisplatin and paclitaxel with respect to antineoplastic activity, as measured by the overall response rate. Overall survival and toxicity will also be assessed. A two-stage sampling design will be used, with a maximum accrual of 51 patients. Paclitaxel will be administered intravenously at a dose of 175 mg/m2 over 3 hours on day 1 of each 21-day cycle. Cisplatin will be administered by a free-flowing intravenous line at a dose of 75 mg/m2 over 30-120 minutes on day 1 of each 21-day cycle. Also, since p53 accumulation in the nuclei of transitional-cell carcinoma cells has been shown to be a statistically significant predictor of disease recurrence and death independent of tumor grade, stage and lymph-node status, the investigators will examine p53 levels in tumor paraffin blocks.