Filgrastim |
G-CSF; Neupogen |
Clinical Trial: Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial
This study is currently recruiting patients.
|
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
Expected Total Enrollment: 60
Study start: March 2001
Last follow-up: January 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Washington
Seattle Cancer Care Alliance, Seattle, Washington, 98109-1023, United States; Recruiting
Jen Roden, B.A. 206-288-2062 jener@u.washington.edu
Julie Gralow, M.D., Principal Investigator
Robert B. Livingston, M.D., Sub-Investigator
Georgiana K. Ellis, M.D., Sub-Investigator
Hannah Linden, M.D., Sub-Investigator
More Information
Record last reviewed: January 2005
Last Updated: January 31, 2005
Record first received: July 9, 2002
ClinicalTrials.gov Identifier: NCT00041470
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Filgrastim (Drug Digest)
- G-CSF (Drug Digest)

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