Phase I study of spiroplatin

Bea C. Tanis, Jan B. Vermorken, Wim W. Ten Bokkel Huinink, Ina Klein, Helen Gall, Allan T. Van Oosterom, Godelaine Simonetti, J. Gordon McVie, Wim J F Van Der Vijgh, Herbert M. Pinedo

Research output: Contribution to journalArticlepeer-review

Abstract

Spiroplatin was investigated in a multicentre phase I study. 67 patients with advanced solid tumours received 151 cycles either by short-term or prolonged infusion, repeated every 3 weeks, at 2.5-40 mg/m2. Myelosuppression and renal toxicity were dose-limiting. Proteinuria, which was dose- and schedule-dependent, indicated glomerular and tubular damage. The maximum tolerated doses (MTD) for poor-risk and good-risk patients were 35 and 40 mg/m2, respectively. The area under the curve (AUC) at the MTD did not correspond with the AUC at the LD10 in mice with ratios of 0.3 for free platinum and 2.6 for total platinum; these were not suitable for predicting the MTD. 1 complete response was observed in a patient with breast cancer and lung metastases and 1 partial response in a patient with adenocarcinoma of the lung. The recommended dose for phase II studies was 30 mg/m2 by 4 h infusion every 3 weeks.

Original languageEnglish (US)
Pages (from-to)268-273
Number of pages6
JournalEuropean Journal of Cancer and Clinical Oncology
Volume27
Issue number3
DOIs
StatePublished - 1991
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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