Spots Global Cancer Trial Database for S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
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Trial Identification
Brief Title: S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Official Title: Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer
Study ID: NCT00015938
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
Detailed Description: OBJECTIVES: * Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel, vinorelbine, and filgrastim (G-CSF). * Determine the response rate (both complete and partial response) and time to progression in patients treated with this regimen. * Determine the qualitative and quantitative toxic effects of this regimen in this patient population. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on day 1, vinorelbine IV over 6-10 minutes on days 8 and 15, and filgrastim (G-CSF) subcutaneously on days 2-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 4-5 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
MBCCOP - Gulf Coast, Mobile, Alabama, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Genesis Medical Center, Davenport, Iowa, United States
Kansas Cancer Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, 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
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
Providence Hospital - Southfield, Southfield, Michigan, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
Danville Radiation Therapy Center, Memphis, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Veterans Affairs Medical Center - Houston, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Contact Details
Name: Julie R. Gralow, MD
Affiliation: Seattle Cancer Care Alliance
Role: STUDY_CHAIR
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