A Phase II trial of suramin monthly x 3 for hormone-refractory prostate carcinoma.
BACKGROUND
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 x 3 one-hour infusion of suramin in 58 patients with hormone-refractory prostate carcinoma.


METHODS
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/m(2) taken intravenously on Day 1, 1620 mg/m(2) on Day 29, and 1292 mg/m(2) on Day 57. All patients received 0.5 mg dexamethasone twice daily.


RESULTS
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.


CONCLUSIONS
Monthly bolus suramin was well tolerated, reduced PSA levels, and induced objective responses, even in patients who previously had received chemotherapy.
Vogelzang
Nicholas J
NJ
Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, Illinois 60637, USA. nvogelza@medicine.bsd.uchicago.edu
Karrison
Theodore
T
Stadler
Walter M
WM
Garcia
Juan
J
Cohn
Helene
H
Kugler
John
J
Troeger
Thomas
T
Giannone
Leonard
L
Arrieta
Rose
R
Ratain
Mark J
MJ
Vokes
Everett E
EE
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D003907:Dexamethasone / Q000008:administration & dosage; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013498:Suramin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D013498:Suramin; D003907:Dexamethasone; D017430:Prostate-Specific Antigen