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

NCT ID: NCT00041067

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2012-01-31

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab, docetaxel, vinorelbine and filgrastim

Trastuzumab, docetaxel, vinorelbine and filgrastim

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

trastuzumab

Intervention Type: BIOLOGICAL

docetaxel

Intervention Type: DRUG

vinorelbine

Intervention Type: DRUG

Interventions

filgrastim

Intervention Type: BIOLOGICAL

trastuzumab

Intervention Type: BIOLOGICAL

docetaxel

Intervention Type: DRUG

vinorelbine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph J. Kash, MD

Role: STUDY_CHAIR

Edward Hospital Cancer Center

Locations

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

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

Jonesboro, Arkansas, United States

Eden Medical Center

Castro Valley, California, United States

Saint Rose Hospital

Hayward, California, United States

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

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Valley Care Medical Center

Pleasanton, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

West Florida Cancer Institute at West Florida Hospital - Pensacola

Pensacola, Florida, United States

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, United States

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

Alton, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Edward Hospital Cancer Center

Naperville, Illinois, United States

Hematology Oncology Consultants - Naperville

Naperville, Illinois, United States

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Southwest Medical Center

Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Stormont-Vail Cancer Center

Topeka, Kansas, United States

St. Francis Comprehensive Cancer Center

Topeka, Kansas, United States

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

CCOP - Wichita

Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Bay Regional Medical Center

Bay City, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

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

Grosse Pointe Woods, Michigan, United States

Ted B. Wahby Cancer Center at Mount Clemens General Hospital

Mount Clemens, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Seton Cancer Institute - Saginaw

Saginaw, Michigan, United States

St. John Macomb Hospital

Warren, Michigan, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, United States

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

St. John's Regional Health Center

Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

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

St Louis, Missouri, United States

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

St. Vincent Healthcare

Billings, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Deaconess Billings Clinic - Downtown

Billings, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

St. James Community Hospital

Butte, Montana, United States

Big Sky Oncology

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, United States

St. Peter's Hospital

Helena, Montana, United States

Glacier Oncology, PLLC

Kalispell, Montana, United States

Kalispell Medical Oncology

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

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

Missoula, Montana, United States

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, United States

Valley Hospital - Ridgewood

Ridgewood, New Jersey, United States

Hematology Oncology Associates, PC

Albuquerque, New Mexico, United States

Lovelace Medical Center

Albuquerque, New Mexico, United States

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

New Mexico Cancer Care Associates

Santa Fe, New Mexico, United States

Highland Hospital of Rochester

Rochester, New York, United States

Interlakes Oncology/Hematology PC

Rochester, New York, United States

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

Rochester, New York, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Rutherford Hospital

Rutherfordton, North Carolina, United States

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, United States

MedCentral - Mansfield Hospital

Mansfield, Ohio, United States

Cleveland Clinic - Wooster

Wooster, Ohio, United States

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, United States

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, United States

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

AnMed Health Cancer Center

Anderson, South Carolina, United States

Bon Secours St. Francis Health System

Greenville, South Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

University of Texas Medical Branch

Galveston, Texas, United States

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Cancer Therapy and Research Center

San Antonio, Texas, United States

University Hospital - San Antonio

San Antonio, Texas, United States

American Fork Hospital

American Fork, Utah, United States

Logan Regional Hospital

Logan, Utah, United States

Cottonwood Hospital Medical Center

Murray, Utah, United States

McKay-Dee Hospital Center

Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Latter Day Saints Hospital

Salt Lake City, Utah, United States

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

Danville Regional Medical Center

Danville, Virginia, United States

Auburn Regional Center for Cancer Care

Auburn, Washington, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

Olympic Hematology and Oncology

Bremerton, Washington, United States

Providence Centralia Hospital Regional Cancer Center

Centralia, Washington, United States

St. Francis Hospital

Federal Way, Washington, United States

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, United States

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, United States

Capital Medical Center

Olympia, Washington, United States

Good Samaritan Cancer Center

Puyallup, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical, PLLC

Seattle, Washington, United States

Group Health Central Hospital

Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Polyclinic First Hill

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

St. Joseph Medical Center at Franciscan Health System

Tacoma, Washington, United States

Allenmore Hospital

Tacoma, Washington, United States

CCOP - Northwest

Tacoma, Washington, United States

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, United States

St. Clare Hospital

Tacoma, Washington, United States

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, United States

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21826527 (View on PubMed)

Other Identifiers

S0215

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000069440

Identifier Type: -

Identifier Source: org_study_id