Phase I and pharmacokinetic study of high volume intraperitoneal aclacinomycin — A (Aclarubicin)

✍ Scribed by Ian G. Kerr; Sherry Archer; Carlo DeAngelis; Susan Farrell; Sherif Hanna; John McKee

• Publisher: Springer US
• Year: 1987
• Tongue: English
• Weight: 379 KB
• Volume: 5
• Category: Article
• ISSN: 0167-6997
• DOI: 10.1007/bf00203543

✦ Synopsis

Aclacinomycin-A (Aclarubicin) is a relatively new anthracycline antibiotic with potential activity against ovarian cancer. Eight patients with various malignancies (4 ovary, 1 breast and ovary, 1 breast, 1 colon, 1 leiomyosarcoma) and intraperitoneal disease were treated in a Phase I trial with escalating doses of intraperitoneal Aclacinomycin. Drug treatments were administered through a peritoneal catheter in a 2 liter fluid volume (1.5~ Dianeal). Seventeen cycles were administered with doses ranging from 25 to 75 mg of Aclacinomycin. Pharmacokinetic studies were carried out in 7 patients. Although high concentrations of Aclacinomycin could be obtained in the peritoneal cavity no drug was detected in the plasma. The major dose-limiting toxicity was chemical peritonitis. Two patients had reduction in the amount of ascites. The recommended dose for Phase II trials is Aclacinomycin 50 mg in 2 liters given every 2 weeks.