RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have metastatic breast cancer that has progressed after previous chemotherapy.
OBJECTIVES: Primary * Determine the time to progression in women with metastatic breast cancer who have progressed after prior chemotherapy and are now treated with amonafide. * Determine the overall response rate (complete and partial response) in patients treated with this drug. * Determine the safety of a phenotypically driven dosing regimen of this drug in these patients. Secondary * Determine the time to tumor response, duration of response, and time to treatment failure in patients treated with this drug. * Determine the overall survival of patients treated with this drug. * Determine the pharmacokinetic profile of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive amonafide IV over 1 hour on days 1-5. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses (beyond 5 courses) at the investigator's discretion. Patients are followed at 30 days and then every 3 months. PROJECTED ACCRUAL: A total of 175 patients will be accrued for this study within 1 year.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.