TY - JOUR
T1 - Phase 1 trial of intraperitoneal AD-32 in gynecologic malignancies
AU - Markman, Maurie
AU - Homesley, Howard
AU - Norberts, D. Andra
AU - Schink, Julian
AU - Abbas, Fouad
AU - Miller, Antonius
AU - Soper, John
AU - Teng, Nelson
AU - Hammond, Neel
AU - Muggia, Franco
AU - Israel, Mervyn
AU - Sweatman, Trevor
PY - 1996/4
Y1 - 1996/4
N2 - 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.
AB - 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.
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U2 - 10.1006/gyno.1996.0102
DO - 10.1006/gyno.1996.0102
M3 - Article
C2 - 8626124
AN - SCOPUS:0029969265
SN - 0090-8258
VL - 61
SP - 90
EP - 93
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 1
ER -