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

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

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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • 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

Substances

  • Organothiophosphorus Compounds
  • Amifostine