Breast Cancer Clinical Trial
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
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.
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.
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