Multicenter phase II study of spiroplatin

Bea C. Tunis, Jan B. Vermorken, Wim W ten Bokkel Huinink, Allan T. Van Oosterom, Ted A W Splinter, Ko J. Vendrik, Dirk T H Sleijfer, Maria E L van der Burg, Eric van der Putten, Herbert M. Pinedo

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)99-103
Number of pages5
JournalOncology
Volume49
Issue number2
DOIs
StatePublished - 1992
Externally publishedYes

Keywords

  • Phase II study
  • Spiroplatin (TNO-6)
  • Unpredictable renal toxicity

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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