INCLUSION CRITERIA:
Patients must fulfill all of the following criteria to be eligible for study admission:
Histologic confirmation of breast adenocarcinoma, to be confirmed by the department of pathology at the enrolling institution, and having incurable, locally advanced or metastatic breast cancer. (Primary Stage IV disease, some Stage III may be eligible) for example, a patient with T4 and /or N2-3 disease who cannot receive doxorubicin or who has already received other therapy. Chemotherapy-naive, locally advanced patients should not be enrolled unless discussed with the Principal Investigator, Dr. Swain. Some patients may not have tissue available for histologic confirmation of breast adenocarcinoma. If these patients have clear documentation of breast surgery and prior chemotherapy for breast cancer, they may be enrolled into this trial after review by the Principal Investigator, Dr. Swain.
Age greater than or equal to 18 years.
ECOG performance of 0, 1, or 2.
Measurable extent of disease by RECIST criteria.
Life expectancy of 3 months or greater.
Patients must have adequate bone marrow and organ function defined by the following:
Granulocyte count greater than or equal to 1200/microliters. Those with granulocyte count below 1500/microliters should be approved by the Principal Investigator, Dr. Swain;
Platelet count greater than or equal to 100,000/microliters;
Total bilirubin less than or equal to 1.5X institutional upper limit of normal, or in patients with clinical evidence Gilberts' disease, less than or equal to 3X upper limit of normal;
ALT/SGPT and AST/SGOT less than or equal to 2.5X institutional upper limit of normal (ULN);
Creatinine within normal institutional limits or if above institutional ULN, measured creatinine clearance greater than or equal to 40 ml/min.
Patients of childbearing potential must be willing to use an effective means of contraception during their participation on trial. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
Greater than 4 weeks from prior radiation or chemotherapy; more than 2 weeks from prior hormonal therapy; and more than 6 weeks from prior treatment with nitrosoureas or mitomycin.
No serious intercurrent medical illness.
The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol.
EXCLUSION CRITERIA:
Patients with any of the following will be excluded from study entry:
Pregnant or nursing women are not eligible; neither are women or men of childbearing potential unless using effective contraception as determined by the patient's physician.
Patients with evidence of CNS metastases by brain MRI or contrast head CT within the 4 weeks prior to enrollment, unless control has been achieved with either radiation or surgical resection at least six months prior to enrollment on study.
Patients who are poor medical risk because of other non malignant systemic disease or active, uncontrolled infection.
Prior craniospinal radiation, or total body irradiation (TBI).
Patients receiving other investigational drugs, other breast cancer chemotherapy, hormonal therapy, or immunotherapy (bisphosphonates for the treatment of bone metastases are acceptable), and the following cytochrome p450 3A4 inhibitors: amiodarone, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, indinavir, nelfinadir, ritonavir, and saquinavir.
Grade 2 or greater sensory, motor or cranial neuropathy or neuropathic pain. If this neuropathy is clearly due to underlying breast cancer, the enrollment may be permitted. This decision will be made by Principal Investigator, Dr. Swain.
Patients with known prior severe hypersensitivity reactions to agents containing Cremophor (registered trademark) EL.
Patients receiving G-CSF (filgrastim or pegfilgrastim) or thrombopoietin (or other platelet growth factors) within the 4 weeks prior to enrollment (erythropoietin is allowed).
Warren Grant Magnuson Clinical Center (CC)