Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00039520|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel Drug: sulindac||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||July 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039520
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Mary Cianfrocca, DO||Fox Chase Cancer Center|