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Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure the qualitative and quantitative toxicity of this regimen.

Outcome Time Frame:

<= 18 months

Safety Issue:

Yes

Principal Investigator

Julie R. Gralow, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

00-5891

NCT ID:

NCT00041470

Start Date:

March 2001

Completion Date:

August 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Seattle Cancer Care AllianceSeattle, Washington  98109