Stage IV Breast Cancer Clinical Trial
Official title:
A Phase 1/2 Study of Bcl-2 Antisense Oligonucleotide G3139 in Combination With Doxorubicin and Docetaxel in Metastatic and Locally Advanced Breast Cancer
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. 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.
PRIMARY OBJECTIVES:
I. To evaluate the pharmacokinetics of G3139, doxorubicin and docetaxel in breast cancer
patients receiving G3139/AT therapy. (Phase I) II. To determine the safety of bcl-2 antisense
oligonucleotide G3139 (GenasenseTM) together with docetaxel plus doxorubicin (AT) in patients
with metastatic and locally advanced breast cancer (LABC). (Phase I) III. To determine the
therapeutic efficacy of neoadjuvant G3139 in combination with AT chemotherapy in patients
with LABC. (Phase II) IV. To further evaluate the safety of bcl-2 antisense oligonucleotide
G3139 (GenasenseTM) together with docetaxel plus doxorubicin (AT) in patients with locally
advanced breast cancer (LABC). (Phase II)
SECONDARY OBJECTIVES:
I. To determine the clinical and imaging response to neoadjuvant G3139/AT in the breast and
the axillary lymph nodes. (Phase II) II. To determine the disease-free survival of breast
cancer patients treated with neoadjuvant G3139/AT. (Phase II) III. To further define the
pharmacokinetics of G3139/AT. (Phase II) IV. To evaluate the role of Bcl-2 expression as a
predictor of response to neoadjuvant G3139/AT therapy. (Phase II) V. To obtain serial breast
cancer samples from patients treated with G3139. (Phase II)
OUTLINE: This is an open-label, dose-escalation study of oblimersen.
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.
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