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Home > "N" Clinical Trials Conditions > Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial  Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial
Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Gralow, Julie, M.D. , Amgen,Bristol-Myers Squibb,GlaxoSmithKline
Synopsis: 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;
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 60
Location and Contact Information:
Seattle Cancer Care Alliance *Recruiting*
Seattle, Washington, 98109-1023
United States
Recruiting Laurel Brash 206-288-1227
Additional Information:
Study ID Numbers: 00-5891;
Study Start Date: March 2001
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041470
Other Breast Cancer Studies:
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3. Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
4. Docetaxel and Flavopiridol to Treat Breast Cancer
5. A Pilot Trial of Sequential Chemotherapy with Antimetabolite Induction, High-Dose Alkylating Agent Consolidation with Peripheral Blood Progenitor Cell Support, and Intensification with Paclitaxel and Doxorubicin for Patients with High-Risk Breast Cancer
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Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial
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