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A Phase II trial of suramin monthly × 3 for hormone-refractory prostate carcinoma
Article first published online: 10 NOV 2003
Copyright © 2003 American Cancer Society
Volume 100, Issue 1, pages 65–71, 1 January 2004
How to Cite
Vogelzang, N. J., Karrison, T., Stadler, W. M., Garcia, J., Cohn, H., Kugler, J., Troeger, T., Giannone, L., Arrieta, R., Ratain, M. J. and Vokes, E. E. (2004), A Phase II trial of suramin monthly × 3 for hormone-refractory prostate carcinoma. Cancer, 100: 65–71. doi: 10.1002/cncr.11867
- Issue published online: 17 DEC 2003
- Article first published online: 10 NOV 2003
- Manuscript Accepted: 12 SEP 2003
- Manuscript Revised: 4 SEP 2003
- Manuscript Received: 20 MAY 2003
- National Cancer Institute (NCI)
- Early Therapeutics Development with Phase II Emphasis. Grant Number: CM-17102-01
- University of Chicago Cancer Research Center. Grant Number: CA-0350076 CCSG
- chemotherapy-refractory prostate carcinoma;
- monthly suramin;
- prostate-specific antigen
The goal of the current study was to determine the prostate-specific antigen (PSA) and objective response rates and the pharmacokinetics associated with a monthly × 3 one-hour infusion of suramin in 58 patients with hormone-refractory prostate carcinoma.
A PSA response was defined as a > 50% reduction in the PSA level from baseline for at least 3 consecutive evaluations over a minimum of 6 weeks. The suramin dose was 2400 mg/m2 taken intravenously on Day 1, 1620 mg/m2 on Day 29, and 1292 mg/m2 on Day 57. All patients received 0.5 mg dexamethasone twice daily.
Among 56 evaluable patients (median entry PSA level, 229.5 ng/mL), there were 21 PSA responders (37.5%). Among 27 patients with measurable disease, there were 5 responders (4 partial and 1 complete). The median overall survival time was 15.3 months. Grade III fatigue (14.1%) was the predominant toxicity observed. Suramin plasma levels remained high even 3 months after treatment was discontinued. Among the 12 evaluable patients who previously had received chemotherapy, the PSA response rate was 42%; one response was observed among 4 patients with measurable disease, and the median survival was 12 months.
Monthly bolus suramin was well tolerated, reduced PSA levels, and induced objective responses, even in patients who previously had received chemotherapy. Cancer 2004;100:65–71. © 2003 American Cancer Society.