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

Tracking Information

First Received Date ^ICMJE

July 9, 2002

Last Updated Date

February 20, 2008

Start Date ^ICMJE

March 2001

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To measure the qualitative and quantitative toxicity of this regimen.
To measure response rates, time to progression and survival in patients so treated.

Change History

Complete list of historical versions of study NCT00041470 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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;

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Paclitaxel
Drug: Vinorelbine
Drug: Trastuzumab
Drug: Filgrastim

Study Arms / Comparison Groups

Experimental: 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

August 2008

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00041470

Responsible Party

Julie Gralow, M.D., University of Washington

Study ID Numbers ^ICMJE

00-5891

Study Sponsor ^ICMJE

Gralow, Julie, M.D.

Collaborators ^ICMJE

Amgen
Bristol-Myers Squibb
GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Julie R. Gralow, M.D.

University of Washington

Information Provided By

Gralow, Julie, M.D.

Verification Date

February 2008

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