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About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Lesion must be outside of the previously irradiated field
No known CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Recovered from prior chemotherapy
At least 6 months since prior adjuvant chemotherapy (taxanes allowed)
At least 4 weeks since prior chemotherapy for advanced disease
No more than 1 prior chemotherapy regimen for advanced disease
No other concurrent chemotherapy
Endocrine therapy
Radiotherapy
See Disease Characteristics
At least 4 weeks since prior radiotherapy
No prior radiotherapy ≥ 30% of functioning bone marrow
No concurrent radiotherapy
Surgery
Other
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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