Phase II trial of toremifene in androgen-independent prostate cancer - A Penn cancer clinical trials group trial

Toremifene has antiestrogenic and estrogenic properties in vitro and in viv o. In addition, it may have antiangiogenesis and antimicrotubule properties at higher doses. Studies have demonstrated the efficacy of this agent in t he treatment of metastatic breast cancer. We performed a phase II trial of toremifene in patients with androgen-independent prostate cancer (AIPC). Pa tients with an increasing prostate-specific antigen level despite castrate testosterone levels and antiandrogen withdrawal were eligible, Patients cou ld not have received prior salvage hormonal therapy or chemotherapy. Patien ts received toremifene at 300 mg/m(2)/d orally (maximum dose 640 mg/d). Fif teen patients were treated. Patients received treatment for a median of 13 weeks (range, 4-30 weeks). The median age was 72 years (range, 58-80 years) . The median Eastern Cooperative Oncology Group performance status was 0. T he treatment was well tolerated and toxicity was mild. Two patients had gra de III hepatic toxicity; one had grade III hyperglycemia. There were no tre atment-related deaths. No objective responses were demonstrated. In summary , toremifene is not effective therapy for AIPC at the dose and schedule eva luated in this trial.