Randomized Phase II Study of Docetaxel and Prednisone With or Without OGX-011 in Patients With Metastatic Castration-Resistant Prostate Cancer

• DOI: 10.1200/jco.2009.26.8771
• Publication Date: 2010-08-24T02:59:35Z
• Authors: Kim N. Chi; Sebastien J. Hotte; Evan Y. Yu; Dongsheng Tu; Bernhard J. Eigl; Ian Tannock; Fred Saad; Scott North; Jean Powers; Martin E. Gleave; Elizabeth A. Eise...
• Keywords: Clusterin; Clinical endpoint

To determine the clinical activity of OGX-011, an antisense inhibitor clusterin, in combination with docetaxel/prednisone patients metastatic castration-resistant prostate cancer.Patients were randomly assigned 1:1 to receive either (arm A) or without B) OGX-011 640 mg intravenously weekly. The primary end point was proportion a prostate-specific antigen (PSA) decline ≥ 50% from baseline, experimental therapy being considered interest if PSA more than 60%. Secondary points objective response rate, progression-free survival (PFS), overall (OS), and changes serum clusterin.Eighty-two accrued, 41 each arm. adverse effects included rigors fevers. After cycle 1, median clusterin decreased by 26% arm A increased 0.9% B (P < .001). declined 58% 54% B. Partial occurred 19% 25% arms B, respectively. Median PFS OS times 7.3 months (95% CI, 5.3 8.8 months) 23.8 16.2 not reached), respectively, 6.1 3.7 8.6 16.9 12.8 25.8 months), Baseline factors associated improved on exploratory multivariate analysis Eastern Cooperative Oncology Group performance status 0 (hazard ratio [HR], 0.27; 95% 0.14 0.51), presence bone lymph node metastases only (HR, 0.45; 0.25 0.79), treatment assignment 0.50; 0.29 0.87).Treatment docetaxel well tolerated evidence biologic effect survival. Further evaluation is warranted.