Final report on phase I trial of WR-2721 before protracted fractionated radiation therapy.
Publication/Presentation Date
6-1-1988
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.
Volume
14
Issue
6
First Page
1119
Last Page
1122
ISSN
0360-3016
Published In/Presented At
Kligerman, M. M., Turrisi, A. T., 3rd, Urtasun, R. C., Norfleet, A. L., Phillips, T. L., Barkley, T., & Rubin, P. (1988). Final report on phase I trial of WR-2721 before protracted fractionated radiation therapy. International journal of radiation oncology, biology, physics, 14(6), 1119–1122. https://doi.org/10.1016/0360-3016(88)90387-2
Disciplines
Medicine and Health Sciences
PubMedID
2454903
Department(s)
Department of Medicine
Document Type
Article