Multicenter phase II study of spiroplatin.
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.
Tanis
B C
BC
Free University Hospital, Amsterdam, The Netherlands.
Vermorken
J B
JB
ten Bokkel Huinink
W W
WW
van Oosterom
A T
AT
Splinter
T A
TA
Vendrik
K J
KJ
Sleijfer
D T
DT
van der Burg
M E
ME
van der Putten
E
E
Pinedo
H M
HM
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
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C040757:spiroplatin