Phase II trial of suramin, leuprolide, and flutamide in previously untreated metastatic prostate cancer

N. A. Dawson*, W. D. Figg, M. R. Cooper, O. Sartor, R. C. Bergan, A. M. Senderowicz, S. M. Steinberg, A. Tompkins, B. Weinberger, E. A. Sausville, E. Reed, C. E. Myers

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

26 Scopus citations


Purpose: To assess the efficacy and toxicity of suramin, hydrocortisone, leuprolide, and flutamide in previously untreated metastatic prostate cancer. Patients and Methods: Patients with stage D2 and poor-prognosis stage D1 prostate cancer were given suramin on a pharmacokinetically derived dosing schedule to maintain suramin concentrations between 175 and 300μg/mL. Additionally, all patients received flutamide 250 mg orally three times daily, initiated on day 1 and continued until disease progression; depot leuprolide 7.5 mg intramuscularly begun on day 5 and repeated every 4 weeks indefinitely; and replacement doses of hydrocortisone. Results: Fifty patients were entered onto the study: 48 with stage D2 and two with stage D1 disease. The median age was 59 years (range, 42 to 79) and 31 patients had a Karnofsky performance status (KPS) of 100%. Forty-five patients had bane metastases and 25 had measurable soft tissue disease. Forty-one (82%) had severe disease. The overall response rate in 49 assessable patients was three complete responses (CRs) and 30 partial responses (PRs) for an overall response rate of 67%. Eighteen patients have died. The median survival time has not been reached, with a median potential follow-up duration of 44 months. Grade 3 to 4 toxicity was seen in 38% of patients and was predominantly hematologic and reversible. Conclusion: The high response rate and prolonged survival in a poor-prognosis group of patients with metastatic prostate cancer warrant a phase III randomized comparison of this regimen versus hormonal therapy alone. Toxicity was moderate and reversible.

Original languageEnglish
Pages (from-to)1470-1477
Number of pages8
JournalJournal of Clinical Oncology
Issue number4
StatePublished - Apr 1997


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