Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00258388
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OGX011, Docetaxel and Prednisone custirsen sodium - OGX011, Docetaxel and Prednisone prednisone - OGX011, Docetaxel and Prednisone docetaxel - Docetaxel plus prednisone prednisone - Docetaxel plus prednisone docetaxel -
- Primary Outcome Measures
Name Time Method Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study 2 years
- Secondary Outcome Measures
Name Time Method Toxicity 2 years Time to treatment failure 2 years
Trial Locations
- Locations (13)
London Regional Cancer Program
🇨🇦London, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, Canada
University of Washington
🇺🇸Seattle, Washington, United States
Cross Cancer Institute
🇨🇦Edmonton, Canada
QEII Health Sciences Center
🇨🇦Halifax, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Canada
Atlantic Health Sciences Corporation
🇨🇦Saint John, Canada
Odette Cancer Centre
🇨🇦Toronto, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Canada