Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- Case Comprehensive Cancer Center
- Study ID
- NCT00075673
- Phase
- PHASE1
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Not accepted
Interventions
- celecoxib — DRUGPatients receive oral celecoxib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- vinorelbine ditartrate — DRUGPatients receive oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Study Details
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.
Key Dates
- Start date
- Nov 30, 2003
- Status verified
- Jul 2020
- Primary completion
- Sep 30, 2004
- Completion
- Feb 28, 2005
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
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. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5055 | - |
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