Final report on phase I trial of WR-2721 before protracted fractionated radiation therapy.
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.
Kligerman
M M
MM
University of Pennsylvania, Philadelphia 19104.
Turrisi
A T
AT
Urtasun
R C
RC
Norfleet
A L
AL
Phillips
T L
TL
Barkley
T
T
Rubin
P
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009369:Neoplasms / Q000532:radiotherapy; D009946:Organothiophosphorus Compounds / Q000008:administration & dosage*; D010166:Palliative Care; D011879:Radiotherapy Dosage; D011882:Radiotherapy, High-Energy / Q000379:methods*; D013997:Time Factors
D009946:Organothiophosphorus Compounds; D004999:Amifostine