Weekly docetaxel and bortezomib in the treatment of patients with advanced hormone refractory prostate cancer (HRPC): A Minnie Pearl Cancer Research Network phase II trial

4735 Background: Docetaxel (75mg/m2 every 3 weeks) is now standard first-line treatment for patients (pts) with HRPC. Bortezomib, a novel proteosome inhibitor, has shown single-agent activity in pts with refractory HRPC. In an effort to improve efficacy of treatment, we evaluated the combination of docetaxel and bortezomib in this multicenter, community-based phase II trial. Methods: Eligibility criteria: metastatic HRPC; no previous chemotherapy; ECOG PS 0–2; measurable metastatic disease or rising PSA levels with osseous metastasis; serum creatinine ≤ 2mg/dl; adequate hepatic and bone marrow function; informed consent. All patients received docetaxel 30mg/m2 IV and bortezomib 1.6mg/m2 IV both given on days 1, 8, 15 of each 28-day cycle. Bortezomib was administered 60 minutes after infusion of docetaxel. Pts were evaluated for response after 8 weeks of treatment; treatment continued in responding patients for 6 cycles. Results: 30 of a planned 50 pts enrolled between 7/03 and 10/04: median age, 70 years;...