Phase I trial of a new nitrosourea, CGP 6809, given every 2 weeks.
A phase I study was carried out on a new water-soluble nitrosourea, 6-deoxy-3,5 di-O-methyl 6-(3 methyl-3-nitrosoureido)-alpha-D-glucofuranoside (EDMN, CGP 6809), given every 2 weeks. A total of 18 patients received doses of 1, 2, 3, and 3.75 g/m2 as a 2- to 5-h infusion. Toxicity principally involved nausea and vomiting, hepatotoxicity, and abdominal pain. There was no evidence of cumulative toxicity. The dose of 3.75 g/m2 was not exceeded because in a previous phase I study, 4.5 g/m2 every 6 weeks was not tolerated; the recommended dose for phase II studies is 3.75 g/m2 every 2 weeks.
Creaven
P J
PJ
Department of Clinical Pharmacology and Therapeutics, Roswell Park Memorial Institute, New York State Department of Health, Buffalo 14263.
Cowens
J W
JW
Huben
R
R
Petrelli
N
N
Karakousis
C
C
Traynor
D
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D009607:Nitrosourea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
D000970:Antineoplastic Agents; D009607:Nitrosourea Compounds; C035871:CGP 6809