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EGFR ANTIBODY 225 IN METASTATIC RENAL CELL CARCINOMA

EGFR ANTIBODY 225 IN METASTATIC RENAL CELL CARCINOMA
转移性肾细胞癌中的 EGFR 抗体 225
批准号:
6303000
负责人:
FRANCISCO ROBERT
金额:
$2.95万
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2000-11-30

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中文摘要
翻译
这是一项在转移性肾细胞癌患者中使用表皮生长因子受体(EGFR)抗体的II期临床试验。该研究的主要目的是确定两周一次静脉输注C225治疗开始后,该患者的进展时间是否从4个月增加一倍至8个月。54例患者入组本研究(1例来自UAB,因为管理问题)。完成1个疗程的患者进展时间为98至332天。记录了一个部分反应和两个次要反应。主要副作用为3级皮肤毒性,表现为毛囊性皮疹和指甲改变,停止治疗后完全消退
英文摘要
This is a phase II clinical trial using an antibody to the epidermal growth factor receptor (EGFR) in patients with metastatic renal cell carcinoma. The primary objective of the study was to determine whether the time to progression in this patient population is doubled from 4 months to 8 months following the initiation of treatment with C225 when administered biweekly intravenous infusions. Fifty-four patients were enrolled in this study (one from UAB, because of administrative issues). Time to progression for patients completing = 1 course of therapy ranges from 98 to 332 days. One partial and two minor responses were recorded. The primary side effects were grade = 3 skin toxicities manifested as follicular rash and nail had changes, which fully resolve after cessation of treatment
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