A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer
- Determine the efficacy of OGX-011 and docetaxel, in terms of objective tumor response
rate, in women with locally advanced or metastatic breast cancer.
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine the time to progression and overall survival of patients treated with this
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
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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Objective response measured by RECIST criteria after accrual of 14 evaluable patients
Stephen Chia, MD
British Columbia Cancer Agency
United States: Federal Government