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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 Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
CCOP - Columbia River Oncology Program Portland, Oregon  97225
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
CCOP - Northwest Tacoma, Washington  98405-0986
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
University of California Davis Cancer Center Sacramento, California  95817
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Great Falls Clinic Great Falls, Montana  59405
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Latter Day Saints Hospital Salt Lake City, Utah  84143
St. Luke's Mountain States Tumor Institute - Boise Boise, Idaho  83712-6297
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Southwest Medical Center Liberal, Kansas  67901
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Eden Medical Center Castro Valley, California  94546
Saint Rose Hospital Hayward, California  94545
Highland General Hospital at St. George's University School of Medicine Oakland, California  94602
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
Edward Hospital Cancer Center Naperville, Illinois  60540
Hematology Oncology Consultants - Naperville Naperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Stormont-Vail Cancer Center Topeka, Kansas  66604
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Bay Regional Medical Center Bay City, Michigan  48708
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Highland Hospital of Rochester Rochester, New York  14620
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Cleveland Clinic - Wooster Wooster, Ohio  44691
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Cancer Therapy and Research Center San Antonio, Texas  78229
University Hospital - San Antonio San Antonio, Texas  78229
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
Capital Medical Center Olympia, Washington  98502
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health System Tacoma, Washington  98405-3004
Allenmore Hospital Tacoma, Washington  98411-0414
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith, Arkansas  72903
West Florida Cancer Institute at West Florida Hospital - Pensacola Pensacola, Florida  32514
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Auburn Regional Center for Cancer Care Auburn, Washington  98002
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Rutherford Hospital Rutherfordton, North Carolina  28139
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
MedCentral - Mansfield Hospital Mansfield, Ohio  44903
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Billings Clinic Cancer Center Billings, Montana  59107-5100
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
Mercy General Hospital Sacramento, California  95819
Valley Hospital - Ridgewood Ridgewood, New Jersey  07450
Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens, Michigan  48043
Lovelace Medical Center Albuquerque, New Mexico  87108
Providence Centralia Hospital Regional Cancer Center Centralia, Washington  98531
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center Jonesboro, Arkansas  72401-9320
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106