title: Phase II trial of zeniplatin (CL 286,558), a new patinum compound, in patients with advanced ovarian cancer previously treated with organoplatinum-based therapy.
abstract: There is a critical need to find new chemotherapeutic agents that are active in platinum-refractory ovarian cancer. A phase II trial of zeniplatin (CL 286,558), a third-generation platinum compound, was conducted in 31 patients with advanced ovarian cancer to examine the safety and activity of the agent when used as a salvage treatment in individuals previously exposed to organoplatinum-based therapy. In general the drug was well tolerated, with moderate emesis and bone marrow suppression being observed in most patients. An unexpected side-effect was significant fever, of unknown etiology, which was noted in 16% of patients. Out of 20 patients, 2 (10%; 95% confidence intervals: 1%-32%) with clinically defined platinum-refractory disease achieved a partial response. Unfortunately, although we have defined definite but modest activity for zeniplatin in platinum-refractory ovarian cancer, further development of this drug has been discontinued because of the severe renal toxicity observed in other clinical trials of this cytotoxic agent.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, N.Y.
authors.forename: M
authors.initials: M
authors.lastname: Markman
authors.forename: L C
authors.initials: LC
authors.lastname: DeMarco
authors.forename: M
authors.initials: M
authors.lastname: Birkhofer
authors.forename: D
authors.initials: D
authors.lastname: Budman
authors.forename: T
authors.initials: T
authors.lastname: Hakes
authors.forename: B
authors.initials: B
authors.lastname: Reichman
authors.forename: S
authors.initials: S
authors.lastname: Rubin
authors.forename: W
authors.initials: W
authors.lastname: Jones
authors.forename: R
authors.initials: R
authors.lastname: Barakat
authors.forename: J
authors.initials: J
authors.lastname: Curtin
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C060594:zeniplatin; D016190:Carboplatin