Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074100
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-12-10
Brief Title:
Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
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 investigators 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 investigators 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000341687 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-03080 | None | None | None |