LEUCOVORIN AND HIGH-DOSE FLUOROURACIL IN METASTATIC PROSTATE-CANCER -A PHASE-II TRIAL OF THE PIEDMONT-ONCOLOGY-ASSOCIATION

We performed a Phase II trial of oral leucovorin and high-dose fluorou racil (5FU) in hormone refractory patients with metastatic prostate ca ncer who had not had prior chemotherapy. 5FU was given as a 24-hour in fusion at a dosage of 4 g/m(2) and oral leucovorin at a dosage of 50 m g every 6 hours for four doses, starting with the infusion of 5FU. Fif teen patients were treated and three were not evaluable for response. There were no complete (CR) or partial responses (PR) in 12 evaluable patients (95% confidence interval for CR + PR of 0 to 26%). Three pati ents had stable disease and the remainder progressed. Toxicities were generally mild to moderate, but one patient died of sepsis while neutr openic. This dose and schedule of leucovorin and 5FU is not better tha n single-agent 5FU in patients with metastatic prostate cancer.