RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor cells less resistant to the drugs. PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy.
OBJECTIVES: Primary * 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. Secondary * Determine the objective response rate and duration in patients treated with these regimens. * Determine the safety and toxic effects of these regimens in these patients. * Determine the overall and progression-free survival of patients treated with these regimens. 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 unacceptable toxicity. * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
640mg IV for 2 hours - Cycle 1: Days -7, -5, -3, 1, 8, 15 (4 week cycle) Subsequent cycles: weekly on days 1, 8, 15 (3 week cycles)
75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)
5mg PO BID
University of Washington
Seattle, Washington, United States
Tom Baker Cancer Centre
Calgary, Canada
Cross Cancer Institute
Edmonton, Canada
QEII Health Sciences Center
Halifax, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Canada
BCCA - Cancer Centre for the Southern Interior
Kelowna, Canada
London Regional Cancer Program
London, Canada
CHUM - Hopital Notre-Dame
Montreal, Canada
Atlantic Health Sciences Corporation
Saint John, Canada
Odette Cancer Centre
Toronto, Canada
...and 3 more locations
Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study
Time frame: 2 years
Toxicity
Time frame: 2 years
Time to treatment failure
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.