Zeniplatin in patients with advanced ovarian cancer, a phase II study with a third generation platinum complex.
25 patients with residual or recurrent ovarian cancer were treated with the new platinum complex zeniplatin (CL 286,558) and 23 patients were evaluable for response. Responses were achieved in 4 patients, 1 complete and 3 partial remissions (16%). 7 patients had stable disease and 12 patients had tumour progression. At a median follow-up of 12 months, the median progression-free survival in responding patients was 11 months and overall survival 81%. The median overall survival of progressive patients amounted to 9 months, indicating the advanced stage of disease in most patients. Renal function was monitored by isotope clearance studies. There was no significant change in effective renal plasma flow (ERPF) or glomerular filtration rate (GFR) in 10 patients who completed six cycles of treatment. 1 patient with a marginal creatinine clearance at baseline suffered from sudden and severe renal failure during the first cycle. Zeniplatin may be active in relapsing, platinum-pretreated patients, and has no direct effects on renal function as measured by isotope clearance. Despite these findings, occasional nephrotoxicity may occur in patients with compromised kidney function, even with prophylactic hydration, and thus limit the application of this new analogue.
Willemse
P H
PH
Department of Medical Oncology, University Hospital Groningen, The Netherlands.
Gietema
J A
JA
Mulder
N H
NH
de Vries
E G
EG
Meijer
S
S
Bouma
J
J
Birkhofer
M
M
Rastogi
R B
RB
Sleijfer
D T
DT
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001783:Blood Flow Velocity / Q000187:drug effects; D016190:Carboplatin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007668:Kidney / Q000098:blood supply; D007674:Kidney Diseases / Q000139:chemically induced; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D012074:Remission Induction; D014839:Vomiting / Q000139:chemically induced
D000970:Antineoplastic Agents; C060594:zeniplatin; D016190:Carboplatin