This phase II trial is studying how well FR901228 works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES: I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic breast cancer. SECONDARY OBJECTIVES: I. Determine the clinical activity of this drug, in terms of progression-free survival, in these patients. OUTLINE: This is a multicenter study. Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2.4-12.3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Given IV
Optional correlative studies
M D Anderson Cancer Center
Houston, Texas, United States
Efficacy (complete and partial response) according to RECIST
Time frame: Up to 14 months
Progression-free survival
Time frame: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months
Toxicity as measured by the standard WHO grading system
Time frame: Up to 14 months after completion of study treatment
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