Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00074100|
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: amonafide dihydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy|
|Study Start Date :||August 2003|
|Actual Study Completion Date :||September 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074100
|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|