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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Objective response measured by RECIST criteria after accrual of 14 evaluable patients
Toxicity
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Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada