NCT00258375

OGX-011 and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, 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 kill more tumor cells by making tumor cells more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving OGX-011 together with docetaxel works in treating women with locally advanced or metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * Determine the efficacy of OGX-011 and docetaxel, in terms of objective tumor response rate, in women with locally advanced or metastatic breast cancer. Secondary * Determine the tolerability and toxicity of this regimen in these patients. * Determine the time to progression and overall survival of patients treated with this regimen. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15 of course 1 and on days 1, 8, and 15 of all subsequent courses. Patients also receive docetaxel IV over 1 hour on days 1 and 8 of all courses. Treatment repeats every 21 days\* for up to 10 courses in the absence of disease progression or unacceptable toxicity. NOTE: \*Course 1 is 28 days in length and all subsequent courses (courses 2-10) are 21 days in length. After completion of study treatment, patients are followed at 4 weeks and then periodically until disease progression. PROJECTED ACCRUAL: Approximately 42 patients will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	custirsen sodium
DRUG	docetaxel

Timeline

• Start date: 2005-10-21
• Primary completion: 2007-02-23
• Completion: 2008-09-22
• First posted: 2005-11-24
• Last updated: 2023-08-04

Locations

5 sites across 1 country: Canada