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Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer Clinical research trials and Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer. Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer  Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephKash, Study Chair, Edward Hospital Cancer Center
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting David Gandara 916-734-3772
Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez, California, 94553
United States
Recruiting David Gandara 925-372-2064
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Glenn Mills 318-221-8411
David Grant Medical Center *Recruiting*
Travis Air Force Base, California, 94535
United States
Recruiting David Gandara 707-423-7300
Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield, Michigan, 48075
United States
Recruiting Anibal Drelichman 313-552-0620
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit, Michigan, 48201-1932
United States
Recruiting Lawrence Flaherty 313-576-1000
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Veterans Affairs Medical Center - Portland *Recruiting*
Portland, Oregon, 97207
United States
Recruiting Craig Nichols 503-220-8262
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting William Schubach 206-764-2265
Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City, Utah, 84148
United States
Recruiting Wolfram Samlowski 801-582-1565
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112-5550
United States
Recruiting Wolfram Samlowski 801-585-0255
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-587-7566
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7353
United States
Recruiting Sarah Taylor 913-588-6029
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting John Barstis 310-825-5268
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Daniel Petrylak 212-305-1731
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
CCOP - Beaumont *Recruiting*
Royal Oak, Michigan, 48073-6769
United States
Recruiting David Decker 248-551-7695
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-1850
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
Veterans Affairs Medical Center - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Gauri Varadhachary 713-791-1414 ext. 5340
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Michael Doukas 859-257-4500
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Abdul-Rahman Jazieh 513-584-3830
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Danville Radiation Therapy Center *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Mohammad Jahanzeb 901-523-8990
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Scott Lippman 713-745-3672
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431-5000
United States
Recruiting Rajat Bannerji 253-968-2504
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton, Ohio, 45428-1002
United States
Recruiting Howard Gross 937-268-6511
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix, Arizona, 85012
United States
Recruiting Thomas Kummet 602-277-5551
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-589-5250
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paul Petruska 314-577-8854
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-6346
Veterans Affairs Medical Center - Temple *Recruiting*
Temple, Texas, 76504
United States
Recruiting Phalguni Mukhopadhyay 254-778-4811 ext. 4809
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Richard Fisher 585-275-0842
Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati, Ohio, 45220-2288
United States
Recruiting Abdul-Rahman Jazieh 513-861-3100 ext. 6537
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston, South Carolina, 29401-5799
United States
Recruiting Andrew Turrisi 843-792-273
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Randall Holcombe 714-456-5153
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
Veterans Affairs Medical Center - Albany *Recruiting*
Albany, New York, 12208
United States
Recruiting James Holland 518-462-3311 ext. 2328
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Geoffrey Weiss 210-617-5120
Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting James Thigpen 601-362-4471
Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City, Missouri, 64128
United States
Recruiting Sarah Taylor 816-861-4700 ext. 491
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Joseph Szumowski 510-465-8570
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cheryl Willman 505-272-5837
Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87108-5138
United States
Recruiting Douglas Clark 505-243-4039
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Anthony Elias 720-848-1622
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Nirmala Bhoopalam 708-202-2782
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
Edward Hospital Cancer Center *Recruiting*
Naperville, Illinois, 60540
United States
Recruiting Joseph Kash 630-527-3788
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0565
United States
Recruiting Robert Whitehead 409-772-1164
Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting Laurence Baker 734-769-7100
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-8000
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0912
United States
Recruiting Laurence Baker 734-936-3983
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Thomas Miller 520-626-2667
Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Geoffrey Weiss 210-617-5120
Brooke Army Medical Center *Recruiting*
Fort Sam Houston, Texas, 78234-6200
United States
Recruiting Mitchell Garrison 210-916-0504
CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting Patrick Henry 314-569-6573
Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson, Arizona, 85723
United States
Recruiting Thomas Miller 520-792-1450 ext. 16631
Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-270-0501
Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Bart Barlogie 501-526-2873
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington, Kentucky, 40502-2236
United States
Recruiting Michael Doukas 859-281-4956
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa, California, 95403
United States
Recruiting Ian Anderson 707-521-3859
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting William Robinson 806-355-9703
CCOP - Montana Cancer Consortium *Recruiting*
Billings, Montana, 59101
United States
Recruiting Patrick Cobb 406-259-2245
Additional Information:
Study ID Numbers: CDR0000069440; SWOG-S0215
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041067
Other Recurrent Breast Cancer Studies:
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2. Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
3. Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
4. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
5. Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
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Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
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