Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy|
|Study Start Date:||August 2003|
|Study Completion Date:||September 2004|
- 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.
- 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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Clifford A. Hudis, MD||Memorial Sloan-Kettering Cancer Center|