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Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer


OBJECTIVES:

- Determine the 1-year survival of women with HER-2-negative stage IV breast cancer
treated with docetaxel, vinorelbine, and filgrastim (G-CSF).

- Determine the response rate (both complete and partial response) and time to
progression in patients treated with this regimen.

- Determine the qualitative and quantitative toxic effects of this regimen in this
patient population.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1, vinorelbine IV over 6-10 minutes on days
8 and 15, and filgrastim (G-CSF) subcutaneously on days 2-21. Treatment repeats every 21
days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 4-5 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV carcinoma of the breast

- HER-2 negative

- 0 or 1+ DAKO (2+ DAKO allowed if fluorescence in situ hybridization [FISH]
negative)

- Weak or no staining on immunohistochemistry test

- No amplification by FISH

- No effusions or ascites as only site of disease

- No brain or CNS disease or metastases

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- Not specified

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Zubrod 0-2

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- SGOT or SGPT no greater than 1.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Not specified

Other:

- No clinically significant pre-existing grade 2 or greater motor or sensory peripheral
neuropathy unless due to cancer

- No known sensitivity to E. coli-derived proteins

- No prior severe hypersensitivity reaction to drugs formulated with polysorbate 80

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy other than 1 prior adjuvant or neoadjuvant chemotherapy program
for primary disease

- At least 6 months since prior chemotherapy

- Prior adjuvant anthracycline allowed

- No prior taxanes (docetaxel or paclitaxel)

Endocrine therapy:

- Prior adjuvant hormonal therapy for metastatic disease allowed

- No concurrent hormonal therapy

Radiotherapy:

- At least 3 weeks since prior radiotherapy

Surgery:

- At least 2 weeks since prior surgery and recovered

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Julie R. Gralow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance

Authority:

United States: Federal Government

Study ID:

CDR0000068575

NCT ID:

NCT00015938

Start Date:

May 2001

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
MBCCOP - HawaiiHonolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Loyola University Medical CenterMaywood, Illinois  60153
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Providence Alaska Medical CenterAnchorage, Alaska  99508
University of California Davis Cancer CenterSacramento, California  95817
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Danville Radiation Therapy CenterMemphis, Tennessee  38104
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Kansas Cancer Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7357
Genesis Medical CenterDavenport, Iowa  52804