Phase I evaluation of SOAz (1,3,3,5,5 pentakis(aziridino)-1 lambda 6, 2,4,6,3 lambda 5, 5 lambda 5 thiatriaza-diphosphorine-1-oxide) in a weekly schedule.
Eleven patients with advanced cancer were treated with SOAz, the first aziridino substituted inorganic heterocyclic compound to undergo phase I clinical trials. The agent was administered as a rapid i.v. infusion once a week in a dose of 50, 75 or 100 mg/m2. Severe myelotoxicity, which was prolonged and delayed in onset, precluded continuing treatment for more than three courses in 9 of 11 patients. In two patients thrombocytopenia showed no signs of recovery 9 and 11 weeks after the last infusion. Two minor responses were noted and there was one therapy-related death. Because of severe myelotoxicity, which is cumulative and may be irreversible, this treatment schedule seems unsuitable for phase II studies.
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use / Q000633:toxicity*; D001389:Azirines / Q000008:administration & dosage / Q000627:therapeutic use / Q000633:toxicity*; D001855:Bone Marrow Diseases / Q000139:chemically induced; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D013921:Thrombocytopenia / Q000139:chemically induced
D000970:Antineoplastic Agents; D001389:Azirines; C035161:pentazirinocyclodiphosphathiazene