title: Multicenter phase II study of spiroplatin.
abstract: Spiroplatin was investigated in a multicenter phase II study, during which the drug was given over 4 h. 64 Patients with nine different solid tumors received 141 cycles of spiroplatin at a dose of 30 mg/m2 every 3 weeks. Most important side effects included nausea, vomiting, myelosuppression, and renal toxicity. Four of 11 evaluable patients with prior cisplatin developed increases in serum creatinine (3 transient, 1 died of renal failure). Of 51 patients without prior cisplatin 2 had a transient increase in serum creatinine levels, and 2 showed persistent changes, in 1 of them leading to hemodialysis. Pre- and posthydration did not reduce drug-induced nephrotoxicity. Only 3 patients showed a response; 1 with renal cell carcinoma, 1 with ovarian carcinoma, and 1 with malignant melanoma. Based on the absence of striking antitumor activity and on the presence of severe unpredictable renal toxicity, the study was stopped prematurely.
authors.affiliation: Free University Hospital, Amsterdam, The Netherlands.
authors.forename: B C
authors.initials: BC
authors.lastname: Tanis
authors.forename: J B
authors.initials: JB
authors.lastname: Vermorken
authors.forename: W W
authors.initials: WW
authors.lastname: ten Bokkel Huinink
authors.forename: A T
authors.initials: AT
authors.lastname: van Oosterom
authors.forename: T A
authors.initials: TA
authors.lastname: Splinter
authors.forename: K J
authors.initials: KJ
authors.lastname: Vendrik
authors.forename: D T
authors.initials: DT
authors.lastname: Sleijfer
authors.forename: M E
authors.initials: ME
authors.lastname: van der Burg
authors.forename: E
authors.initials: E
authors.lastname: van der Putten
authors.forename: H M
authors.initials: HM
authors.lastname: Pinedo
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D004341:Drug Evaluation; D006801:Humans; D007674:Kidney Diseases / Q000139:chemically induced; D007958:Leukocyte Count / Q000187:drug effects; D009369:Neoplasms / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010976:Platelet Count / Q000187:drug effects
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C040757:spiroplatin