Spots Global Cancer Trial Database for Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer

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Trial Identification

Brief Title: Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer

Official Title: A Phase I Study of Weekly Administration of Oral Navelbine in Combination With the COX-2 Inhibitor Celebrex in Relapsed and/or Metastatic Breast Cancer

Study ID: NCT00075673

Conditions

Breast Cancer

Interventions

celecoxib

vinorelbine ditartrate

Study Description

Brief Summary: RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vinorelbine with celecoxib may kill more tumor cells. PURPOSE: Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib in treating women who have relapsed or metastatic breast cancer.

Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer. * Determine the safety profile of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral celecoxib twice daily on days 1-21 and oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of celecoxib and vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.