CISPLATIN PLUS PACLITAXEL IN ADVANCED CARCINOMA OF THE UROTHELIUM

作为单一的化疗药物，顺铂和紫杉醇各有 已被证明在治疗移行细胞癌方面有临床应用价值 尿路上皮炎。因此，这项第二阶段的研究将检查这两种药物 在这些主题中结合在一起。主要目标是评估 顺铂和紫杉醇联合用药对 抗肿瘤活性，以总应答率衡量。 总体存活率和毒性也将进行评估。分两个阶段进行 将采用抽样设计，最大受试者为51人。 紫杉醇将以175毫克/平方米的剂量静脉注射 每21天周期的第一天超过3小时。顺铂将成为 以75毫克/平方米的剂量通过自由流动的静脉输液给药 在每个21天周期的第一天，超过30-120分钟。另外，由于P53 在移行细胞癌细胞的细胞核中积聚 被证明是疾病复发的有统计学意义的预测因素 与肿瘤分级、分期和淋巴结状况无关的死亡 调查人员将检查肿瘤石蜡块中的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.