Phase I study of suramin combined with doxorubicin in the treatment of androgen-independent prostate cancer

Shi Ming Tu, Lance C. Pagliaro, Marie E. Banks, Robert J. Amato, Randall E. Millikan, Nagla A. Bugazia, Timothy Madden, Robert A. Newman, Christopher J. Logothetis

Research output: Contribution to journalArticle

17 Scopus citations

Abstract

In this study, we determined the maximum tolerated plasma concentration of suramin (within the predetermined study target range) when combined with doxorubicin in the treatment of androgen-independent prostate cancer. Twenty- four patients received suramin dosages based on proportional adjustment of the steady-state plasma suramin concentration to achieve the targeted plasma concentrations of 50-100, 101-150, 151-200, or 201-250 μg/ml. Doxorubicin (20 mg/m2) was administered i.v. over 24 h at weekly intervals. Suramin was given i.v. over 2 h twice weekly. Patients received treatment until dose- limiting toxicity or disease progression. Side effects similar to those reported for suramin and doxorubicin administered as individual agents were observed. Dose-limiting motor neuropathy developed in three patients (13%). Twelve of 24 evaluable patients (50%; 95% confidence interval, 28-71%) and 6 of 10 evaluable patients (60%; 95% confidence interval, 26-88%) had a >50% decrease of prostate-specific antigen and measurable lesions, respectively. The maximum tolerated plasma level of suramin when combined with doxorubicin was 151-200 μg/ml. Future studies on suramin combined with doxorubicin or other agents could be performed using a fixed dosing scheme with a targeted suramin steady-state plasma concentration of 200 μg/ml.

Original languageEnglish (US)
Pages (from-to)1193-1201
Number of pages9
JournalClinical Cancer Research
Volume4
Issue number5
StatePublished - May 1 1998

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Tu, S. M., Pagliaro, L. C., Banks, M. E., Amato, R. J., Millikan, R. E., Bugazia, N. A., Madden, T., Newman, R. A., & Logothetis, C. J. (1998). Phase I study of suramin combined with doxorubicin in the treatment of androgen-independent prostate cancer. Clinical Cancer Research, 4(5), 1193-1201.