Phase 1 trial of intraperitoneal AD-32 in gynecologic malignancies

Maurie Markman, Howard Homesley, D. Andra Norberts, Julian Schink, Fouad Abbas, Antonius Miller, John Soper, Nelson Teng, Neel Hammond, Franco Muggia, Mervyn Israel, Trevor Sweatman

Research output: Contribution to journalArticle

Abstract

AD-32 (N-trifluoroacetyladriamycin-14-valerate), an analogue of doxorubicin, was examined for intraperitoneal (ip) administration in a phase 2 trial involving 25 patients with advanced gynecologic malignancies. At an AD-32 dose of 600 mg/m2, the limiting toxicity was grade 4 neutropenia (64% of patients), while severe abdominal pain was relatively uncommon (12%). Intraperitoneal AD-32 administration was associated with a 200-fold pharmacokinetic advantage for cavity exposure, compared to the systemic compartment. At the 600 mg/m2 dose level, 4 of 9 patients (44%) with ascites experienced control of malignant fluid reaccumulation. Based on the results of this phase 1 trial, further exploration of a possible role for the ip administration of AD-32 in individuals with gynecological malignancies appears indicated, particularly in patients with either small volume residual disease after initial systemic chemotherapy or in those with intractable ascites.

Original languageEnglish (US)
Pages (from-to)90-93
Number of pages4
JournalGynecologic oncology
Volume61
Issue number1
DOIs
StatePublished - Apr 1996
Externally publishedYes

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ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Cite this

Markman, M., Homesley, H., Norberts, D. A., Schink, J., Abbas, F., Miller, A., Soper, J., Teng, N., Hammond, N., Muggia, F., Israel, M., & Sweatman, T. (1996). Phase 1 trial of intraperitoneal AD-32 in gynecologic malignancies. Gynecologic oncology, 61(1), 90-93. https://doi.org/10.1006/gyno.1996.0102