Mitomycin C and aminoglutethimide in the treatment of metastatic prostatic cancer: a phase II study.

In a phase II study, 24 patients with metastatic prostatic cancer were treated with mitomycin C 15 mg/m2 i.v. every 6 weeks, combined with aminoglutethimide 250 mg twice a day. A low dose of 37.5 mg cortisone acetate was supplied daily to compensate for adrenal cortical suppression. A partial response was demonstrated in 4 of 24 evaluable patients with bi-dimensionally measurable metastases. Stable disease occurred in 8 patients over a period of more than 6 months. Within the maximum cumulative dose limit of 2 mg/kg body weight mitomycin C, toxicity was observed in 21 cases, including 2 deaths due to treatment toxicity. The poor response rate and high toxicity suggest that the addition of aminoglutethimide does not enhance the effect of mitomycin C in these patients.