Expired Study
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Houston, Texas 77030


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.

Study summary:

OBJECTIVES: 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. Phase II: - 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.


Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed breast cancer. 2. To be eligible for the phase I component of this study, patients must have stage IIIB, IIIC or IV breast cancer. These include patients with T4, any N, M0; any T, N3, M0; any T, any N, M1. 3. To be eligible for the phase II component, patients must have stage IIIA, IIIB, or IIIC breast cancer. These include patients with T4, any N, M0; any T, N2-3, M0; T3, N1, M0. Patients with ipsilateral supraclavicular lymph node metastases (IIIC) are eligible. Patients with evidence of distant metastases (stage IV) are not eligible. 4. Measurable disease is not required for patients participating in the phase I component. Measurable disease is required for the phase II component. 5. Prior G3139, taxane or anthracycline therapy is not allowed. 6. Life expectancy of greater than 6 months. 7. ECOG performance status 0, 1, or 2 (Karnofsky >60%; see Appendix A). 8. Patients must have normal organ and marrow function, as defined in the protocol. 9. Normal cardiac function (LVEF 45% or greater) as documented by MUGA scan and/or echocardiogram. Exclusion Criteria: 1. Patients with metastatic breast cancer participating in the phase I component may not have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the phase I study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2. For patients with locally advanced breast cancer participating in the phase II component may not have received any chemotherapy for breast cancer. 3. Patients may not be receiving any other investigational agents. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to G3139 or other agents used in the study. Patients are excluded if known hypersensitivity to drugs formulated in polysorbate 80 (Tween 80). 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Patients with neuropathy grade 2 or higher. 7. Pregnant women are excluded from this study because G3139 is an oligonucleotide agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with G3139, breastfeeding should be discontinued if the mother is treated with G3139. These potential risks may also apply to other agents used in this study, such as doxorubicin and docetaxel.



Primary Contact:

Study Chair
Francisco J. Esteva, MD
M.D. Anderson Cancer Center

Backup Contact:


Location Contact:

Houston, Texas 77030
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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