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

This study has been completed.
Sponsor:
Collaborators:
Amgen
Bristol-Myers Squibb
GlaxoSmithKline
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00041470
First received: July 9, 2002
Last updated: September 13, 2012
Last verified: September 2012

July 9, 2002
September 13, 2012
March 2001
August 2008   (final data collection date for primary outcome measure)
  • To measure the qualitative and quantitative toxicity of this regimen. [ Time Frame: <= 18 months ] [ Designated as safety issue: Yes ]
  • To measure response rates, time to progression and survival in patients so treated. [ Time Frame: <= 4 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00041470 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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;
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Paclitaxel
    50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
  • Drug: Vinorelbine
    20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
  • Drug: Trastuzumab
    4 mg/kg IV loading dose day 1 of first week followed by 2 mg/kg IV maintenance dose on each subsequent week. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
  • Drug: Filgrastim
    5 mcg/kg daily including the day of IV chemotherapy. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Experimental: 1
Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Interventions:
  • Drug: Paclitaxel
  • Drug: Vinorelbine
  • Drug: Trastuzumab
  • Drug: Filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041470
00-5891
No
University of Washington
University of Washington
  • Amgen
  • Bristol-Myers Squibb
  • GlaxoSmithKline
Principal Investigator: Julie R. Gralow, M.D. University of Washington
University of Washington
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP