Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer. [ Time Frame: Courses (21 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2003|
|Study Completion Date:||February 2005|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
- 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.
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5055|
|Principal Investigator:||Paula Silverman, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|