title: [A phase I study of DWA2114R].
abstract: Phase I study of DWA2114R, a new platinum analogue, was conducted in 39 patients with various tumor types by a group of 13 institutions. Of the 39 patients entered in this study, 35 were evaluable. The starting dose was 40 mg/m2 (1N) and the drug was administered i.v. for 20-30 min, escalating stepwisely up to 1,000 mg/m2 (25 N). The dose limiting factor (DLF) was leukocytopenia, especially neutrocytopenia, and the maximum tolerated dose (MTD) was more than 1,000 mg/m2. Major clinical toxicity was gastrointestinal. Hepatotoxicity and nephrotoxicity were mild. Following administration of the drug, plasma concentrations of total and filterable platinum (Pt) showed a triphasic and biphasic decays. Excretion into urine within 24 hours was in the range of 54.2% to 92.2% of the administered platinum. The recommended dose of phase II study was 800-1,000 mg/m2, repeating every 3-4 weeks.
authors.affiliation: Dept. of Medicine, Aichi Cancer Center, Nagoya, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ariyoshi
authors.forename: A
authors.initials: A
authors.lastname: Wakui
authors.forename: K
authors.initials: K
authors.lastname: Hasegawa
authors.forename: H
authors.initials: H
authors.lastname: Niitani
authors.forename: M
authors.initials: M
authors.lastname: Ogawa
authors.forename: Y
authors.initials: Y
authors.lastname: Sakai
authors.forename: H
authors.initials: H
authors.lastname: Majima
authors.forename: H
authors.initials: H
authors.lastname: Furue
authors.forename: H
authors.initials: H
authors.lastname: Miyake
authors.forename: T
authors.initials: T
authors.lastname: Taguchi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000970:Antineoplastic Agents; C058816:DWA 2114; D016190:Carboplatin