Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039520
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2002-06-06
Brief Title:
Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast
Status:
COMPLETED
Status Verified Date:
2014-05
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining sulindac with docetaxel in treating women who have metastatic or recurrent breast cancer
PURPOSE Phase II trial to study the effectiveness of combining sulindac with docetaxel in treating women who have metastatic or recurrent breast cancer
Detailed Description:
OBJECTIVES
Determine the response rate of women with metastatic or recurrent adenocarcinoma of the breast treated with sulindac and docetaxel
Determine the time to progression of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive oral sulindac twice daily Patients also receive docetaxel IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed within 3-4 weeks
PROJECTED ACCRUAL Approximately 12-33 patients will be accrued for this study
Determine the response rate of women with metastatic or recurrent adenocarcinoma of the breast treated with sulindac and docetaxel
Determine the time to progression of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive oral sulindac twice daily Patients also receive docetaxel IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed within 3-4 weeks
PROJECTED ACCRUAL Approximately 12-33 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 |
|---|---|---|---|
| NCI-G02-2080 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-01031 | None | None | None |
| FCCC-63723 | None | None | None |