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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.
AuthorsB C Tanis, J B Vermorken, W W ten Bokkel Huinink, A T van Oosterom, T A Splinter, K J Vendrik, D T Sleijfer, M E van der Burg, E van der Putten, H M Pinedo
JournalOncology (Oncology) Vol. 49 Issue 2 Pg. 99-103 ( 1992) ISSN: 0030-2414 [Print] Switzerland
PMID1574259 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
Chemical References
  • Antineoplastic Agents
  • Organoplatinum Compounds
  • spiroplatin
Topics
  • Antineoplastic Agents (adverse effects)
  • Drug Evaluation
  • Humans
  • Kidney Diseases (chemically induced)
  • Leukocyte Count (drug effects)
  • Neoplasms (drug therapy)
  • Organoplatinum Compounds (adverse effects, therapeutic use)
  • Platelet Count (drug effects)

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