S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer

NCT00041067 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000069440S0215U10CA032102
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 145

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Survival at 1 Year

  1 year

Secondary Outcomes (3)

• Response Rate (Complete and Partial, Confirmed and Unconfirmed)

  response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession

• Progression-free Survival

  2 years

• Toxicity

  toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession

Study Arms (1)

Trastuzumab, docetaxel, vinorelbine and filgrastim

EXPERIMENTAL

Trastuzumab, docetaxel, vinorelbine and filgrastim

Biological: filgrastim; Biological: trastuzumab; Drug: docetaxel; Drug: vinorelbine

Interventions

filgrastim BIOLOGICAL

Trastuzumab, docetaxel, vinorelbine and filgrastim

trastuzumab BIOLOGICAL

Trastuzumab, docetaxel, vinorelbine and filgrastim

docetaxel DRUG

Trastuzumab, docetaxel, vinorelbine and filgrastim

vinorelbine DRUG

Trastuzumab, docetaxel, vinorelbine and filgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (145)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, 72903, United States

Location

Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center

Jonesboro, Arkansas, 72401-9320, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Highland General Hospital at St. George's University School of Medicine

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Valley Care Medical Center

Pleasanton, California, 94588, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Doctors Medical Center - San Pablo Campus

San Pablo, California, 94806, United States

Location

West Florida Cancer Institute at West Florida Hospital - Pensacola

Pensacola, Florida, 32514, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Edward Hospital Cancer Center

Naperville, Illinois, 60540, United States

Location

Hematology Oncology Consultants - Naperville

Naperville, Illinois, 60540, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Stormont-Vail Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Ted B. Wahby Cancer Center at Mount Clemens General Hospital

Mount Clemens, Michigan, 48043, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Seton Cancer Institute - Saginaw

Saginaw, Michigan, 48601, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, 68848-1990, United States

Location

Valley Hospital - Ridgewood

Ridgewood, New Jersey, 07450, United States

Location

Hematology Oncology Associates, PC

Albuquerque, New Mexico, 87106, United States

Location

Lovelace Medical Center

Albuquerque, New Mexico, 87108, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

MedCentral - Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Bon Secours St. Francis Health System

Greenville, South Carolina, 29601, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78209, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

University Hospital - San Antonio

San Antonio, Texas, 78229, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84103, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Auburn Regional Center for Cancer Care

Auburn, Washington, 98002, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Providence Centralia Hospital Regional Cancer Center

Centralia, Washington, 98531-9027, United States

Location

St. Francis Hospital

Federal Way, Washington, 98003, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, 98506-5166, United States

Location

Capital Medical Center

Olympia, Washington, 98507, United States

Location

Good Samaritan Cancer Center

Puyallup, Washington, 98372, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

St. Joseph Medical Center at Franciscan Health System

Tacoma, Washington, 98405-3004, United States

Location

Allenmore Hospital

Tacoma, Washington, 98405, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

St. Clare Hospital

Tacoma, Washington, 98499, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

• Livingston RB, Barlow WE, Kash JJ, Albain KS, Gralow JR, Lew DL, Flaherty LE, Royce ME, Hortobagyi GN. SWOG S0215: a phase II study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer. Breast Cancer Res Treat. 2011 Nov;130(1):123-31. doi: 10.1007/s10549-011-1698-5. Epub 2011 Aug 9.

  PMID: 21826527 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Trastuzumab; Docetaxel; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Study statistician
• Organization: SWOG

206-667-4623

Study Officials

• Joseph J. Kash, MD

  Edward Hospital Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2012
• Last Updated: June 6, 2013
• Results First Posted: June 6, 2013

Record last verified: 2013-05

Locations

US (145)