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

Sponsor:	Gralow, Julie, M.D.
Collaborators:	Amgen Bristol-Myers Squibb GlaxoSmithKline
Information provided by:	Gralow, Julie, M.D.
ClinicalTrials.gov Identifier:	NCT00041470

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	Intervention	Phase
Breast Cancer	Drug: Paclitaxel Drug: Vinorelbine Drug: Trastuzumab Drug: Filgrastim	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Vinorelbine Filgrastim Vinorelbine tartrate Trastuzumab

U.S. FDA Resources

Further study details as provided by Gralow, Julie, M.D.:

Primary Outcome Measures:

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 ]

Enrollment:	40
Study Start Date:	March 2001
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	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.

Arms

Assigned Interventions

1: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041470

Locations

United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023

Sponsors and Collaborators

Gralow, Julie, M.D.

Amgen

Bristol-Myers Squibb

GlaxoSmithKline

Investigators

Principal Investigator:

Julie R. Gralow, M.D.

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Julie Gralow, M.D. )
Study ID Numbers:	00-5891
Study First Received:	July 9, 2002
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00041470 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Vinorelbine
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Trastuzumab
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009