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