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Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer Clinical research trials and Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer. Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer  Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV carcinoma of the breast - HER-2 negative - 0 or 1+ DAKO (2+ DAKO allowed if fluorescence in situ hybridization [FISH] negative) - Weak or no staining on immunohistochemistry test - No amplification by FISH - No effusions or ascites as only site of disease - No brain or CNS disease or metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Not specified Performance status: - Zubrod 0-2 Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT or SGPT no greater than 1.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Not specified Other: - No clinically significant pre-existing grade 2 or greater motor or sensory peripheral neuropathy unless due to cancer - No known sensitivity to E. coli-derived proteins - No prior severe hypersensitivity reaction to 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 adequately treated stage I or II cancer currently in complete remission - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy other than 1 prior adjuvant or neoadjuvant chemotherapy program for primary disease - At least 6 months since prior chemotherapy - Prior adjuvant anthracycline allowed - No prior taxanes (docetaxel or paclitaxel) Endocrine therapy: - Prior adjuvant hormonal therapy for metastatic disease allowed - No concurrent hormonal therapy Radiotherapy: - At least 3 weeks since prior radiotherapy Surgery: - At least 2 weeks since prior surgery and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieGralow, Study Chair, University of Washington
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Genesis Medical Center
Davenport, Iowa, 52804
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0501
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97201-3098
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99519-6604
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: CDR0000068575; SWOG-S0102
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015938
Other Recurrent Breast Cancer Studies:
1. Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast
2. Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
3. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
4. Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer
5. Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Louisiana Clinical Trials
Other Shreveport Clinical Trials
Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
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