WR-2721在长期分割放射治疗前的I期试验最终报告。

Final report on phase I trial of WR-2721 before protracted fractionated radiation therapy.

作者信息

Kligerman M M, Turrisi A T, Urtasun R C, Norfleet A L, Phillips T L, Barkley T, Rubin P

机构信息

University of Pennsylvania, Philadelphia 19104.

出版信息

Int J Radiat Oncol Biol Phys. 1988 Jun;14(6):1119-22. doi: 10.1016/0360-3016(88)90387-2.

DOI:10.1016/0360-3016(88)90387-2

PMID:2454903

Abstract

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.

摘要

这是关于多剂量WR-2721联合放射治疗的初始临床研究（RTOG 80-02）I期方案的最终报告。该研究的主要目的是确定在常规放疗计划前15至30分钟，能够连续多周每日给予的WR-2721的最高剂量。84名患者进入了不同剂量水平组。主要的剂量限制性毒性反应为呕吐、低血压和不适。后一种症状的特征是虚弱、易疲劳和不适感逐渐加重。本研究确定的最大耐受剂量（MTD）为每周4天（周三除外）给予340 mg/m²，持续5周。药物在7分钟内静脉输注。未出现长期血液生化改变。未发生因给予放射防护剂导致的死亡。