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

• Published in: International journal of radiation oncology, biology, physics Vol. 14; no. 6; p. 1119
• Main Authors: Kligerman, M M, Turrisi, 3rd, A T, Urtasun, R C, Norfleet, A L, Phillips, T L, Barkley, T, Rubin, P
• Format: Journal Article
• Language: English
• Published: United States 01-06-1988
• Subjects: Adolescent; Adult; Aged; Amifostine - administration & dosage; Amifostine - adverse effects; Amifostine - pharmacokinetics; Dose-Response Relationship, Drug; Drug Evaluation; Humans; Infusions, Intravenous; Middle Aged; Neoplasms - radiotherapy; Organothiophosphorus Compounds - administration & dosage; Palliative Care; Radiotherapy Dosage; Radiotherapy, High-Energy - methods; Time Factors
• ISSN: 0360-3016
• DOI: 10.1016/0360-3016(88)90387-2

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.