ps-341 in treating women with metastatic breast cancer

Conditions: Recurrent Breast Cancer; Stage IV Breast Cancer

Summary: ps-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. phase ii trial to study the effectiveness of ps-341 in treating women who have metastatic breast cancer

primary objectives: i. determine the efficacy of ps-341, in terms of response rate, in women with metastatic breast cancer. secondary objectives: i. determine the clinical activity of this drug, in terms of progression-free survival, in these women. ii. determine the toxicity profile and tolerability of this drug in these women. iii. determine the pharmacodynamics of this drug in these women. outline: patients receive ps-341 iv over 3-5 seconds twice weekly on weeks 1 and 2. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a maximum of 12-35 patients will be accrued for this study within 9-12 months.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed invasive breast cancer * clinical and/or radiological evidence of stage iv disease * relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting * at least 1 unidimensionally measurable lesion * at least 20 mm by conventional techniques * at least 10 mm by spiral ct scan * no bone metastases as only measurable site * pleural or peritoneal effusions not acceptable as measurable disease * no known brain metastases * hormone receptor status: * estrogen receptor-negative * estrogen receptor-positive * female * performance status - ecog 0-2 * performance status - karnofsky 60-100% * more than 12 weeks * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin normal * ast or alt no greater than 2.5 times upper limit of normal * creatinine normal * creatinine clearance at least 60 ml/min * no acute ischemia or significant conduction abnormality by ekg * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * lvef greater than 50% * no uncontrolled concurrent illness * no psychiatric illness or social situation that would preclude study * no ongoing or active infection * no prior allergic reaction(s) to compounds of similar chemical or biologic composition to ps-341 * no other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier-method contraception * see chemotherapy * see disease characteristics * no more than 1 prior chemotherapy regimen for metastatic disease * high-dose regimen or bone marrow transplantation considered 1 prior regimen * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * prior hormonal therapy for metastatic disease or in adjuvant setting allowed * prior localized radiotherapy allowed if it does not influence the signal evaluable lesion * at least 4 weeks since prior radiotherapy and recovered * at least 2 weeks since prior minor surgery and recovered * at least 4 weeks since prior major surgery and recovered * no other concurrent investigational agent * no other concurrent investigational or commercial agents or therapies to treat this malignancy