Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005054
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-04-06
Brief Title:
Temozolomide in Treating Women With Advanced Breast Cancer
Sponsor:
The Christie NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Temodal 4 Hourly in Progressive Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2001-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating women who have advanced breast cancer
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating women who have advanced breast cancer
Detailed Description:
OBJECTIVES I Assess the therapeutic activity of temozolomide in terms of tumor response progression free and overall survival in women with advanced breast cancer II Assess the extent of ATase depletion and DNA methylation in the peripheral blood of these patients undergoing this regimen and investigate the relationship between these parameters and tumor response
OUTLINE Patients receive oral temozolomide every 4 hours for a total of 5 doses Treatment continues every 28 days for a minimum of 2 courses and a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients are followed at 30 days and then every 2 months thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study
OUTLINE Patients receive oral temozolomide every 4 hours for a total of 5 doses Treatment continues every 28 days for a minimum of 2 courses and a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients are followed at 30 days and then every 2 months thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-99047 | None | None | None |
| CHNT-H98-198-50 | None | None | None |