Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT00074100
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: