NCT00039520

Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	sulindac

Timeline

• Start date: 2002-01-01
• Primary completion: 2004-06-01
• Completion: 2008-07-01
• First posted: 2003-01-27
• Last updated: 2014-05-06

Locations

1 site across 1 country: United States