NCT00258388

Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	custirsen sodium	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)
DRUG	docetaxel	75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)
DRUG	prednisone	5mg PO BID

Timeline

• Start date: 2005-09-28
• Primary completion: 2007-11-08
• Completion: 2011-01-18
• First posted: 2005-11-24
• Last updated: 2023-08-04

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study