Breast Cancer
Conditions
Keywords
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
Brief summary
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.
Detailed description
OBJECTIVES: Primary * Determine the efficacy of OGX-011 and docetaxel, in terms of objective tumor response rate, in women with locally advanced or metastatic breast cancer. Secondary * Determine the tolerability and toxicity of this regimen in these patients. * Determine the time to progression and overall survival of patients treated with this regimen. 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic or locally advanced disease * Not curable with standard therapy * 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 * If the sole site of disease is in a previously irradiated field, there must be evidence of disease progression or new lesions in the irradiated field * No known CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Platelet count ≥ 100,000/mm\^3 * Absolute granulocyte count ≥ 1,500/mm\^3 * PTT, PT, and INR normal * No known bleeding disorder Hepatic * Bilirubin normal * AST and ALT ≤ 1.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No significant cardiac dysfunction Immunologic * No active uncontrolled infection * No history of serious allergic reaction to taxanes, including paclitaxel or docetaxel Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No preexisting neuropathy ≥ grade 2 * No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No other serious medical condition or illness that would preclude study participation * No significant neurological disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Prior trastuzumab (Herceptin\^®) allowed 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 prior taxanes for advanced disease * No more than 1 prior chemotherapy regimen for advanced disease * No other concurrent chemotherapy Endocrine therapy * At least 1 week since prior hormonal therapy Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * Low-dose, nonmyelosuppressive radiotherapy allowed within 4 weeks before study entry at the discretion of the investigator * No prior radiotherapy ≥ 30% of functioning bone marrow * No concurrent radiotherapy Surgery * At least 3 weeks since prior major surgery and recovered (wound healing must have occurred) Other * More than 4 weeks since prior investigational agents or new anticancer therapy * No concurrent therapeutic anticoagulation therapy except low-dose oral anticoagulant therapy (i.e., 1 mg of oral warfarin once a day) or low molecular weight heparin * No other concurrent investigational therapy * No other concurrent cytotoxic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response measured by RECIST criteria after accrual of 14 evaluable patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
Countries
Canada