Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075413
Status:
WITHDRAWN
Last Update Posted:
2015-10-02
First Post:
2004-01-09
Brief Title:
Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
A Pilot Phase II Protocol Of Arsenic Trioxide TRISENOX In Subjects With Advanced Carcinoma Of The Breast
Status:
WITHDRAWN
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to identify qualified subjects willing to participate in this study
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 arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well arsenic trioxide works in treating women with locally advanced or metastatic breast cancer
PURPOSE This phase II trial is studying how well arsenic trioxide works in treating women with locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and activity of arsenic trioxide in women with locally advanced or metastatic breast cancer
Determine the qualitative and quantitative toxic effects of this drug in these patients
Secondary
Determine the response in terms of objective tumor response and response duration in patients treated with this drug
Determine the patterns of failure and survival in patients treated with this drug
OUTLINE This is a pilot study
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 for course 1 only Beginning with course 2 and for all subsequent courses patients receive arsenic trioxide on days 1 and 5 of weeks 1-8 Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients who have a complete response CR receive an additional course beyond documentation of CR Patients who have a CR due to local consolidative therapy eg surgery or radiotherapy receive an additional 2 courses beyond CR
Patients are followed for 1 month every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 9-24 months
Primary
Determine the safety and activity of arsenic trioxide in women with locally advanced or metastatic breast cancer
Determine the qualitative and quantitative toxic effects of this drug in these patients
Secondary
Determine the response in terms of objective tumor response and response duration in patients treated with this drug
Determine the patterns of failure and survival in patients treated with this drug
OUTLINE This is a pilot study
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 for course 1 only Beginning with course 2 and for all subsequent courses patients receive arsenic trioxide on days 1 and 5 of weeks 1-8 Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients who have a complete response CR receive an additional course beyond documentation of CR Patients who have a CR due to local consolidative therapy eg surgery or radiotherapy receive an additional 2 courses beyond CR
Patients are followed for 1 month every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 9-24 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 |
|---|---|---|---|
| UTMB-02403 | None | None | None |