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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450515 |
RATIONALE: Drugs used in chemotherapy, such as vinflunine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinflunine together with capecitabine works in treating patients with previously treated metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: capecitabine Drug: vinflunine Procedure: quality-of-life assessment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer |
Estimated Enrollment: | 48 |
Study Start Date: | March 2007 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every other course, and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer meeting the following criteria:
Measurable disease, defined as ≥ 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
No nonmeasurable disease, including any of the following:
No CNS metastasis unless controlled by prior surgery and/or radiotherapy
Hormone receptor status not specified
Hormone-positive tumor must meet at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
No radiotherapy within the past 4 weeks, except if to a nontarget lesion only
No concurrent administration of any of the following:
Study Chair: | Alvaro Moreno, MD | Mayo Clinic |
Investigator: | Philip J. Stella, MD | Ann Arbor Hematology Oncology Associates, PC at St. Joseph Mercy Cancer Center |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000536545, NCCTG-N0632 |
Study First Received: | March 20, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00450515 History of Changes |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IV breast cancer male breast cancer |
Antimetabolites Capecitabine Skin Diseases Breast Neoplasms, Male |
Breast Neoplasms Breast Cancer, Male Breast Diseases Recurrence |
Antimetabolites Capecitabine Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Skin Diseases Antineoplastic Agents Therapeutic Uses Breast Neoplasms Pharmacologic Actions Breast Diseases |