Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095888
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2004-11-09
Brief Title:
3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have refractory metastatic breast cancer Drugs used in chemotherapy such as 3-AP and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Combining 3-AP with gemcitabine may kill more tumor cells
Detailed Description:
OBJECTIVES Primary I Determine antitumor activity of 3-AP Triapine and gemcitabine by measuring tumor size in patients with refractory metastatic breast cancer
Secondary I Determine the safety and tolerability of this regimen in these patients II Determine the time to disease progression in patients treated with this regimen
III Determine the effect of multidrug resistance polymorphisms on pharmacokinetics and toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours followed by gemcitabine IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration
PROJECTED ACCRUAL A total of 30-75 patients will be accrued for this study within 24 months
Secondary I Determine the safety and tolerability of this regimen in these patients II Determine the time to disease progression in patients treated with this regimen
III Determine the effect of multidrug resistance polymorphisms on pharmacokinetics and toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours followed by gemcitabine IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration
PROJECTED ACCRUAL A total of 30-75 patients will be accrued for this study within 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62205 | NIH | None | httpsreporternihgovquickSearchN01CM62205 |
| MC0333 | None | None | None |