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


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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.

Sponsors and Collaborators: 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
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

Tove Thompson, B.A.      206-288-1233    tovethom@u.washington.edu

Washington
      Seattle Cancer Care Alliance, Seattle,  Washington,  98109-1023,  United States; Recruiting
Tove Thompson, B.A.  206-288-1233    tovethom@u.washington.edu 
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

Study ID Numbers:  00-5891
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

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November 18, 2008



Page Updated: June 1, 2005
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