Expired Study
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Seattle, Washington 98109


Purpose:

The purposes of this are: - To determine the highest doses of Taxol and Navelbine that we can safely give to patients; - To determine what kind of side effects are caused by the combination of Taxol, Navelbine and G-CSF; - To determine whether the combination of Taxol, Navelbine and G-CSF is more effective than standard therapy in treating metastatic breast cancer and prolonging life;


Criteria:

INCLUSION To be eligible, volunteers must: - Have stage IV carcinoma of the breast that has been microscopically confirmed - Be age > 18 - Be fully active or ambulatory with symptoms but able to do light work - Have a life expectancy of > 16 weeks - Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin C or nitrosureas) and > 2 weeks from prior hormonal therapy - Have had one or less prior regimens for metastatic disease - Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated EXCLUSION Patients are not eligible if they: - Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases - Are medically unstable - Are pregnant, nursing or unwilling to employ adequate contraception - Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer - Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol - Have hypersensitivity to E. Coli-derived proteins, Filgrastim, or any of its components - Have had prior therapy with Navelbine


NCT ID:

NCT00041470


Primary Contact:

Principal Investigator
Julie R. Gralow, M.D.
University of Washington


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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