monoclonal antibody therapy and docetaxel in treating women with metastatic or recurrent breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent breast cancer.

objectives: * determine the toxicity and safety profile of doxorubicin-monoclonal antibody br96 immunoconjugate (sgn-15) and docetaxel in women with metastatic or recurrent breast cancer. * determine the clinical response rate and duration of response of patients treated with this regimen. outline: patients receive doxorubicin-monoclonal antibody br96 immunoconjugate (sgn-15) iv over 2 hours and docetaxel iv over 30 minutes on day 1 of weeks 1-6. treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed at 4 weeks. projected accrual: a maximum of 45 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic or recurrent breast carcinoma * unresectable disease * previously treated with no more than 2 chemotherapy regimens for metastatic disease or * recurrent within 6 months of adjuvant chemotherapy * must have one of the following: * measurable disease * positive bone scan and elevation of serum tumor marker for adenocarcinoma * serum levels must have increased over 2 consecutive measurements and exceed at least 2 times upper limit of normal * lewis-y antigen expression documented by immunohistochemistry * no brain metastases that are uncontrolled or require active treatment (including steroids) * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * ecog 0-2 life expectancy: * at least 3 months hematopoietic: * hemoglobin at least 10 g/dl * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * no bleeding diathesis hepatic: * bilirubin no greater than 1.5 mg/dl * sgot no greater than 2.5 times normal * alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis present) * amylase/lipase less than 1.5 times normal * hepatitis b and c negative * no hepatic failure renal: * creatinine no greater than 1.5 times upper limit of normal * no renal failure cardiovascular: * lvef greater than 50% by echocardiogram or muga scan * no congestive heart failure other: * hiv negative * no antibody present that detects monoclonal antibody br96 in serum * no peripheral neuropathy grade 2 or greater * no dementia or altered mental status * no other serious underlying medical condition that would preclude study participation * no prior allergic reactions to recombinant human or murine proteins * no uncontrolled peptic ulcer disease * no active viral, bacterial, or systemic fungal infections * no other primary malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix * no serious nonmalignant disease * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 8 weeks since prior therapeutic or diagnostic murine/humanized/human chimeric antibodies chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, mitomycin, or anthracyclines) * no prior cumulative anthracycline of 300 mg/m2 or more * no concurrent antineoplastic agents endocrine therapy: * see disease characteristics * at least 4 weeks since prior hormonal therapy * no concurrent hormonal therapy except estrogen replacement radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * see disease characteristics other: * no other concurrent experimental agents * no concurrent immunosuppressive medications

Keywords: stage iv breast cancer recurrent breast cancer