Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial
This study is currently recruiting patients.
Sponsored by: |
Gralow, Julie, M.D.
Amgen
Bristol-Myers Squibb
GlaxoSmithKline
|
Information provided by: |
Gralow, Julie, M.D. |
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;
Condition
|
Treatment or Intervention |
Phase |
Breast Cancer
|
Drug: Paclitaxel Drug: Vinorelbine Drug: Trastuzumab Drug: Filgrastim
|
Phase I Phase II
|
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further Study Details:
Expected Total Enrollment:
60
Study start: March 2001
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Location
and Contact
Information
Washington Seattle Cancer Care Alliance, Seattle,
Washington,
98109-1023,
United States; Recruiting
Laurel La Brash, R.N.
206-288-1227
labrash@u.washington.edu
Deborah Chielens, R.N.
206-288-1091
dchielen@u.washington.edu
Julie R. Gralow, M.D., Principal Investigator
Robert B. Livingston, M.D., Sub-Investigator
Georgiana K. Ellis, M.D., Sub-Investigator
Hannah M. Linden, M.D., Sub-Investigator
More Information
Study ID Numbers:
00-5891
Record last reviewed:
July 2002
Record first received:
July 9, 2002
ClinicalTrials.gov Identifier:
NCT00041470Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10