Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
- Conditions
- Breast Cancer
- Registration Number
- NCT00074100
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States