FR901228 in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria: Histologically or cytologically confirmed breast cancer Metastatic disease Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan The following are not considered measurable disease: Bone disease only Pleural effusion Peritoneal effusion Must have received prior anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant therapy or for advanced disease Therapy with high-dose regimens or bone marrow transplantation is considered 1 prior regimen No known brain metastases Hormone receptor status: Not specified Male or female Performance status - ECOG 0-1 Performance status - Karnofsky 70-100% More than 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin normal AST or ALT ≤ 2.5 times upper limit of normal Creatinine normal Creatinine clearance ≥ 60 mL/min QTc < 500 msec No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past year No uncontrolled dysrhythmia No poorly controlled angina No other significant cardiac disease No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reaction attributed to compounds of similar chemical or biologic composition to FR901228 No active or ongoing infection No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No concurrent biologic agents No more than 1 prior chemotherapy regimen for metastatic disease More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior FR901228 (depsipeptide) No other concurrent chemotherapy Prior hormonal therapy for metastatic disease or as adjuvant therapy allowed More than 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy More than 2 weeks since prior minor surgery and recovered More than 4 weeks since prior major surgery and recovered Concurrent bisphosphonates allowed provided therapy was initiated ≥ 3 months ago No concurrent agents that cause QTc prolongation No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent drugs known to have histone deacetylase activity (e.g., valproic acid) No other concurrent investigational agents No other concurrent anticancer therapy