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RATIONALE: Drugs used in chemotherapy, such as doxorubicin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and docetaxel by making the tumor cells more sensitive to the drugs.
PURPOSE: This phase I/II trial is studying the side effects and best dose of oblimersen when given together with doxorubicin and docetaxel and to see how well they work in treating women with metastatic or locally advanced breast cancer.
Phase I (completed as of 8/16/04):
- Determine the pharmacokinetics of oblimersen, doxorubicin, and docetaxel in patients with metastatic or locally advanced breast cancer.
- Determine the maximum tolerated dose (MTD) of oblimersen in combination with doxorubicin and docetaxel in these patients.
- Determine the safety of this regimen in these patients.
- Determine the therapeutic efficacy of this regimen at the MTD of oblimersen in a neoadjuvant setting, in terms of pathologic complete response rate, in patients with locally advanced breast cancer.
- Determine the clinical and imaging response in the breast and axillary lymph nodes of patients treated with this regimen.
- Determine the disease-free survival of patients treated with this regimen.
- Determine the role of Bcl-2 expression as a predictor of response to this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of oblimersen.
- Phase I (phase I completed as of 8/16/04): Patients receive oblimersen IV continuously on days 1-6 interrupted only to administer doxorubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 6. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 7-13 or pegfilgrastim SC on day 7. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive doxorubicin, docetaxel, G-CSF or pegfilgrastim, and oblimersen at the MTD as in phase I.
Patients with resectable tumors after 6 courses undergo surgical resection.
Patients are followed every 3-6 months for 5 years.
PROJECTED ACCRUAL: A total of 69 patients (9 patients for phase I [phase I portion of the study completed as of 8/16/04] and 60 patients for phase II) will be accrued for this study within 2 years.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Filgrastim, Oblimersen Sodium, Pegfilgrastim, Docetaxel, Doxorubicin Hydrochloride, Conventional Surgery, Neoadjuvant Therapy
M.D. Anderson Cancer Center at University of Texas
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:55:07-0400
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