ixabepilone in treating patients with locally advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer.

objectives: * determine any antitumor activity of ixabepilone, in terms of objective response rate, in patients with incurable, locally advanced or metastatic breast cancer. * determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients are stratified according to prior taxane therapy (yes vs no). patients (with or without prior taxane exposure) receive ixabepilone iv over 1 hour on days 1-5. an additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone iv over 1 hour on days 1-3 at a higher starting dose. for all patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks. patients removed for unacceptable toxicty are followed periodically. projected accrual: a total of 105 patients (at least 74 with and 21 without prior taxane exposure) will be accrued for this study within 26 months.

Eligibility criteria:
disease characteristics: * histologically confirmed\* adenocarcinoma of the breast * incurable, locally advanced or metastatic disease * primarily stage iv disease, but some inoperable stage iii disease may be eligible (e.g., a patient with t4 and/or n2-3 disease who cannot receive doxorubicin or who has already received other therapy) note: \*patients with no available tissue for histologic confirmation but who have documentation of breast surgery and prior chemotherapy are eligible upon approval of the principal investigator * measurable disease * no evidence of cns metastases by brain mri or contrast head ct scan * cns metastases controlled by radiotherapy or surgical resection at least 6 months prior to study enrollment are allowed * hormone receptor status: * not specified patient characteristics: age * 18 and over sex * female or male menopausal status * not specified performance status * ecog 0-2 life expectancy * at least 3 months hematopoietic * granulocyte count at least 1,200/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than 1.5 times upper limit of normal (uln) (3 times uln if there is clinical evidence of gilbert's disease) * ast and alt no greater than 2.5 times uln renal * creatinine normal or * creatinine clearance greater than 40 ml/min other * no poor medical risk due to other nonmalignant systemic disease * no active uncontrolled infection * no sensory, motor, or cranial neuropathy or neuropathic pain grade 2 or greater (unless neuropathy is clearly due to underlying breast cancer) * no other concurrent serious medical illness * no prior severe hypersensitivity reactions to agents containing cremophor el * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 2 months after study participation prior concurrent therapy: biologic therapy * more than 4 weeks since prior filgrastim (g-csf), pegfilgrastim, or thrombopoietin (or other platelet growth factors) * no concurrent immunotherapy chemotherapy * more than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * no other concurrent chemotherapy for breast cancer endocrine therapy * more than 2 weeks since prior hormonal therapy * no concurrent hormonal therapy radiotherapy * see disease characteristics * no prior craniospinal radiation * no prior total body irradiation * more than 4 weeks since prior radiotherapy surgery * see disease characteristics other * no other concurrent investigational drugs * no concurrent cytochrome p450 3a4 inhibitors, including any of the following: * clarithromycin * erythromycin * troleandomycin * delaviridine * nelfinavir * amprenavir * ritonavir * indinavir * saquinavir * lopinavir * itraconazole * ketoconazole * fluconazole (\> 200 mg/day) * voriconazole * nefazodone * fluvoxamine * verapamil * diltiazem * amiodarone * concurrent bisphosphonates for bone metastases allowed

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