[A phase I study of DWA2114R]

Gan To Kagaku Ryoho. 1992 May;19(5):685-93.
[Article in Japanese]

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.

Publication types

  • English Abstract

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anorexia / chemically induced
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Carboplatin / administration & dosage
  • Carboplatin / adverse effects
  • Carboplatin / analogs & derivatives*
  • Carboplatin / therapeutic use
  • Drug Evaluation
  • Female
  • Humans
  • Infusions, Intravenous
  • Leukopenia / chemically induced
  • Male
  • Middle Aged
  • Neoplasms / blood
  • Neoplasms / drug therapy*
  • Vomiting / chemically induced

Substances

  • Antineoplastic Agents
  • DWA 2114
  • Carboplatin