CISPLATIN PLUS PACLITAXEL IN ADVANCED CARCINOMA OF THE UROTHELIUM

作为单一化疗药物，顺铂和紫杉醇在尿路移行细胞癌中均有临床应用。因此，该ii期研究将检查这两种药物在这些受试者中的联合应用。主要目的是评估顺铂和紫杉醇联合使用的抗肿瘤活性，通过总体缓解率来衡量。总体生存期和毒性也将进行评估。将采用两阶段抽样设计，最多累积51例患者。紫杉醇将在每21天周期的第1天以175 mg/m2的剂量静脉注射3小时。顺铂将在每21天周期的第1天通过自由流动静脉给药，剂量为75mg /m2，持续30-120分钟。此外，由于p53在移行细胞癌细胞细胞核中的积累已被证明是疾病复发和死亡的统计显著预测因子，与肿瘤分级、分期和淋巴结状态无关，研究人员将检测肿瘤石蜡块中的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.