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 — DRUG
    Patients 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 — DRUG
    Patients 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)

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