Cytotoxic chemotherapy and androgen priming in patients with advanced carcinoma of the prostate. A phase II trial of the Piedmont Oncology Association.

Twenty-three patients with advanced prostatic cancer refractory to hormonal therapy were entered into a phase II study of cytotoxic chemotherapy combined with androgen priming. Patients received vincristine 0.5 mg on day 1; fluoxymesterone 10 mg p.o. TID, days 1-5; methotrexate 4 mg/m2 p.o., days 1-7; and cyclophosphamide 500 mg/m2 I.V., day 8. Patients entered had no prior chemotherapy, most were symptomatic but ambulatory (18/23), and almost all had bone metastases (22/23). There were two stable responses and 14 progressions in 16 patients evaluable for response. Hematologic and gastrointestinal toxicities were substantial. Androgen priming was an unsatisfactory method of improving response in this trial.