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Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer


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

Thank you

Trial Information

Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer


OBJECTIVES:

- Determine the 1-year survival of women with HER2-positive stage IV breast cancer
treated with trastuzumab (Herceptin), docetaxel, and vinorelbine with filgrastim
(G-CSF) support.

- Determine the response rate (complete and partial, confirmed and unconfirmed) in the
subset of patients with measurable disease treated with this regimen.

- Determine the progression-free survival of patients treated with this regimen.

- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.

- Obtain tissue blocks for the determination of predictors of response (e.g.,
beta-tubulin mutations) to microtubule interacting agents in this patient population
and for other future studies.

OUTLINE: This is a pilot, multicenter study.

Patients receive docetaxel IV over 1 hour on day 1, filgrastim (G-CSF) subcutaneously on
days 2-21, vinorelbine IV over 6-10 minutes on days 8 and 15, and trastuzumab (Herceptin) IV
over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity. If docetaxel and vinorelbine are discontinued
due to unacceptable toxicity, patients may continue to receive trastuzumab. If trastuzumab
is discontinued due to unacceptable toxicity, patients may continue to receive chemotherapy
with G-CSF support.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18-22.5
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV breast cancer

- Metastasis to the ipsilateral supraclavicular lymph nodes allowed

- HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+
staining confirmed in the adjuvant or metastatic setting

- No effusions or ascites as only sites of disease

- No primary or metastatic brain or central nervous system tumor

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

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

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

Hepatic:

- Bilirubin normal

- aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times
upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Not specified

Cardiovascular:

- left ventricular ejection fraction normal by multigated radionuclide angiography or
echocardiogram (patients who have received prior anthracycline therapy)

- No clinical evidence or history of cardiomyopathy

Other:

- No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except
abnormalities due to cancer

- No prior severe hypersensitivity reaction to docetaxel or other 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 other adequately
treated stage I or II cancer currently in complete remission

- No known sensitivity to E. coli-derived proteins

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 6 months since prior chemotherapy

- Prior anthracycline as adjuvant therapy allowed

- No prior cumulative dose of doxorubicin more than 360 mg/m^2

- No prior cumulative dose of epirubicin more than 720 mg/m^2

- No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease

- No prior docetaxel

- No prior vinorelbine

- Prior paclitaxel allowed

Endocrine therapy:

- Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer 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:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 1 Year

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Joseph J. Kash, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Edward Hospital Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069440

NCT ID:

NCT00041067

Start Date:

September 2002

Completion Date:

January 2012

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
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 - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
CCOP - NorthwestTacoma, Washington  98405-0986
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Great Falls ClinicGreat Falls, Montana  59405
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Latter Day Saints HospitalSalt Lake City, Utah  84143
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Eden Medical CenterCastro Valley, California  94546
Saint Rose HospitalHayward, California  94545
Highland General Hospital at St. George's University School of MedicineOakland, California  94602
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
Edward Hospital Cancer CenterNaperville, Illinois  60540
Hematology Oncology Consultants - NapervilleNaperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Stormont-Vail Cancer CenterTopeka, Kansas  66604
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Bay Regional Medical CenterBay City, Michigan  48708
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Highland Hospital of RochesterRochester, New York  14620
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Capital Medical CenterOlympia, Washington  98502
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, Arkansas  72903
West Florida Cancer Institute at West Florida Hospital - PensacolaPensacola, Florida  32514
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
MedCentral - Mansfield HospitalMansfield, Ohio  44903
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Mercy General HospitalSacramento, California  95819
Valley Hospital - RidgewoodRidgewood, New Jersey  07450
Ted B. Wahby Cancer Center at Mount Clemens General HospitalMount Clemens, Michigan  48043
Lovelace Medical CenterAlbuquerque, New Mexico  87108
Providence Centralia Hospital Regional Cancer CenterCentralia, Washington  98531
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical CenterJonesboro, Arkansas  72401-9320
Hematology Oncology Associates, PCAlbuquerque, New Mexico  87106