FINAL REPORT ON PHASE-I TRIAL OF WR-2721 BEFORE PROTRACTED FRACTIONATED RADIATION-THERAPY
FINAL REPORT ON PHASE-I TRIAL OF WR-2721 BEFORE PROTRACTED FRACTIONATED RADIATION-THERAPY
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DOI：
10.1016/0360-3016(88)90387-2
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发表时间：
1988-06-01
影响因子：
7
通讯作者：
RUBIN, P
中科院分区：
文献类型：
--
作者：
KLIGERMAN, MM;TURRISI, AT;RUBIN, P
这是多剂量WR-2721与放射治疗（RTOG 80-02）的初步临床研究的I期方案的最终报告。该研究的主要目的是确定WR-2721的最高剂量，该剂量可在常规放射治疗计划前15至30分钟每天给予最多周。84例患者进入不同剂量水平。主要的剂量限制性毒性为呕吐、低血压和不适。后一种症状的特征是虚弱、疲劳和不适感增加。本研究确定的最大耐受剂量（MTD）为340 mg/m2，每周4天（周三除外）给药，持续5周。药物在7分钟内通过静脉注射。没有长期的血液化学变化。没有因给予辐射防护剂而死亡。
This is the final report of the Phase I Protocol for the initial clinical study of Multiple Dose WR-2721 with radiotherapy (RTOG 80-02).The essential object of the study was to determine the highest dose of WR-2721 that could be given daily for the greatest number of weeks 15 to 30 minutes before conventional radiation treatment schedules. Eighty-four patients were entered into various dose levels. The major and dose-limiting toxicities were emesis, hypotension and malaise. The latter symptom was characterized by increasing weakness, fatigability, and ill-feeling. The maximum tolerated dose (MTD) established by this study is 340 mg/m2 given 4 days a week (excepting Wednesday) for 5 weeks. The drug is delivered intravenously in 7 minutes. There were no long-term blood chemistry changes. There were no deaths due to the administration of the radioprotector.