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Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: July 8, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041067
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Biological: trastuzumab
Drug: docetaxel
Drug: vinorelbine ditartrate
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at 1 year [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: September 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 CNS 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
  • AST or ALT no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Not specified

Cardiovascular:

  • LVEF normal by MUGA 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041067

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arkansas
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center
Jonesboro, Arkansas, United States, 72401-9320
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
United States, California
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Mercy General Hospital
Sacramento, California, United States, 95819
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
Eden Medical Center
Castro Valley, California, United States, 94546
Highland General Hospital at St. George's University School of Medicine
Oakland, California, United States, 94602
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Saint Rose Hospital
Hayward, California, United States, 94545
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Valley Care Medical Center
Pleasanton, California, United States, 94588
United States, Florida
West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola, Florida, United States, 32514
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
United States, Illinois
Hematology Oncology Consultants - Naperville
Naperville, Illinois, United States, 60540
Edward Hospital Cancer Center
Naperville, Illinois, United States, 60540
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Stormont-Vail Cancer Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
St. John Macomb Hospital
Warren, Michigan, United States, 48093
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens, Michigan, United States, 48043
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63701
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405
Billings Clinic Cancer Center
Billings, Montana, United States, 59107-5100
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Great Falls Clinic
Great Falls, Montana, United States, 59405
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
United States, New Jersey
Valley Hospital - Ridgewood
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
Hematology Oncology Associates, PC
Albuquerque, New Mexico, United States, 87106
Lovelace Medical Center
Albuquerque, New Mexico, United States, 87108
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Highland Hospital of Rochester
Rochester, New York, United States, 14620
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
United States, Ohio
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States, 44903
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84103
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Logan Regional Hospital
Logan, Utah, United States, 84321
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Allenmore Hospital
Tacoma, Washington, United States, 98405
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Capital Medical Center
Olympia, Washington, United States, 98507
Group Health Central Hospital
Seattle, Washington, United States, 98112
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
CCOP - Northwest
Tacoma, Washington, United States, 98405
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Providence Centralia Hospital Regional Cancer Center
Centralia, Washington, United States, 98531-9027
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Polyclinic First Hill
Seattle, Washington, United States, 98122
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
St. Clare Hospital
Tacoma, Washington, United States, 98499
St. Francis Hospital
Federal Way, Washington, United States, 98003
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States, 98405-3004
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Joseph J. Kash, MD Edward Hospital Cancer Center
  More Information

Additional Information:
Publications:
Kash J, Barlow WE, Albain KS, et al.: Phase II Southwest Oncology Group study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer. [Abstract] J Clin Oncol 26 (Suppl 15): A-1033, 2008.

Study ID Numbers: CDR0000069440, SWOG-S0215
Study First Received: July 8, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00041067     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Vinblastine
Antimitotic Agents
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Vinorelbine
Therapeutic Uses
Tubulin Modulators
Trastuzumab
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009