A phase II and pharmacokinetic study of enloplatin in patients with platinum refractory advanced ovarian carcinoma.
This was a study of enloplatin in 18 evaluable patients with platinum refractory ovarian cancer. They received an i.v. infusion of enloplatin over 1.5 h without prehydration every 21 days. One patient had a partial response (6%; 95% CI 0-26%) lasting 2.8 months. The median survival was 9.4 months (95%; CI 5.1-19.7%). Neutropenia was the dose-limiting toxicity. Nephrotoxicity was manageable. Enloplatin is the major form of the free drug in plasma. However, 13.5 h after initiation of treatment, 85% of the drug in plasma is protein bound. Elimination of the drug is mainly renal. Enloplatin pharmacokinetics is similar to that of carboplatin. Thus, the plasma pharmacokinetics of enloplatin is dictated by the cyclobutanedicarboxylato (CBDCA) ligand and not the novel amino ligand.
Kudelka
A P
AP
University of Texas MD Anderson Cancer Center, Section of Gynecologic Medical Oncology, Houston 77030-4095, USA.
Siddik
Z H
ZH
Tresukosol
D
D
Edwards
C L
CL
Freedman
R S
RS
Madden
T L
TL
Rastogi
R
R
Hord
M
M
Kim
E E
EE
Tornos
C
C
Mante
R
R
Kavanagh
J J
JJ
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018579:Patient Selection; D015996:Survival Rate
D000970:Antineoplastic Agents; D016190:Carboplatin; C060593:enloplatin