ogx-011 and docetaxel in treating women with locally advanced or metastatic breast cancer

Conditions: Breast Cancer

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.

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.

Eligibility 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

Keywords: stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer recurrent breast cancer