Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT00039520
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2002-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
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:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA006927 | NIH | None | https://reporter.nih.gov/quic… | View |
| FCCC-01031 | None | None | View | |
| FCCC-63723 | None | None | View | |
| NCI-G02-2080 | None | None | View |