A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory Prostate Cancer
- Determine the efficacy, in terms of prostate-specific antigen response, of docetaxel
and prednisone with or without OGX-011 in patients with hormone-refractory locally
recurrent or metastatic prostate cancer.
- Determine the objective response rate and duration in patients treated with these
- Determine the safety and toxic effects of these regimens in these patients.
- Determine the overall and progression-free survival of patients treated with these
OUTLINE: This is a multicenter, randomized, open-label study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive a loading dose of OGX-011 IV over 2 hours on days -7, -5, and
-3. Patients then receive OGX-011 IV over 2 hours on days 1, 8, and 15, docetaxel IV
over 1 hour on day 1, and oral prednisone twice daily on days 1-21. Treatment repeats
every 3 weeks for up to 10 courses in the absence of disease progression or
- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice
daily on days 1-21. Treatment repeats every 3 weeks for up to 10 courses in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study
Kim N. Chi, MD
British Columbia Cancer Agency
Canada: Health Canada
|University of Washington||Seattle, Washington 98195|