Phase II trial of circadian infusion floxuridine (FUDR) in hormone refractory metastatic prostate cancer

Circadian administration of chemotherapy has been reported to decrease toxi city and possibly enhance efficacy. Between March 1991 and December 1993, 1 8 evaluable patients with progressive, hormone-refractory metastatic prosta te cancer were treated in this phase II trial of circadian infusion floxuri dine (FUDR). The drug was delivered through a central venous catheter using a CADD-Plus computerized pump such that approximately 70% of the drug was administered between 3 and 9 p.m. and the rest (30%) was administered betwe en 9 p.m. and 3 p.m. The dose of FUDR was 0.15 mg/kg/day x 14 days every 4 weeks. A total of 79 complete cycles was administered. Two of 18 evaluable patients (11.1%) had decreases in PSA lasting five and eight months. No objective responses or improvement in bone scans was noted . The major toxicity observed was diarrhea. Although circadian infusion FUD R is feasible and tolerable, it has limited activity in hormone refractory prostate cancer.