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Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer Clinical research trials and Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer. Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer  Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer
Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer,Male Breast Cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone and carboplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with ixabepilone and carboplatin in treating patients who have HER2/neu-positivemetastatic breast cancer.
Details: OBJECTIVES: Primary - Determine the response rate in patients with HER2/neu-positive metastatic breast cancer treated with trastuzumab (Herceptin®), ixabepilone, and carboplatin. Secondary - Determine the time to disease progression and time to treatment failure in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Determine the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. - Patients receive trastuzumab (Herceptin®) IV over 30 minutes* on days 1, 8, 15, and 22 and ixabepilone IV over 1 hour and carboplatin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity. NOTE: *Trastuzumab is given over 90 minutes on day 1 of course 1 (induction therapy) only. - Maintenance therapy: Patients receive trastuzumab IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years from study entry. PROJECTED ACCRUAL: A total of 10-60 patients will be accrued for this study within 1-6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Metastatic disease - HER2/neu-positive (3+) disease by immunohistochemistry or fluorescent in situ hybridization - At least 1 objectively measurable disease parameter - No brain metastases as the only site of measurable disease - Previously irradiated tumors are not considered measurable disease, except for recurrent disease located in an area of prior adjuvant irradiation (e.g., axilla or chest wall) - No untreated brain metastases - Previously treated brain metastases that have responded to prior radiotherapy and/or surgery are allowed - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Granulocyte count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - AST and ALT 1.5 times upper limit of normal (ULN) (2.0 times ULN for patients with liver involvement by tumor) Renal - Creatinine 1.5 mg/dL Cardiovascular - LVEF within lower limit of normal by MUGA or echocardiogram - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective nonhormonal contraception - No prior severe (grade 3 or 4) hypersensitivity reaction to drugs formulated in polyoxyethylated castor oil (Cremophor EL) - No peripheral neuropathy - No other malignancy within the past 5 years except curatively treated squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior trastuzumab (Herceptin®) for metastatic disease - No concurrent pegfilgrastim Chemotherapy - No prior ixabepilone for metastatic disease - No prior carboplatin for metastatic disease - No other prior chemotherapy for metastatic disease - No prior cumulative doxorubicin dose > 360 mg/m^2 - No prior cumulative epirubicin dose > 640 mg/m^2 Endocrine therapy - Prior hormonal therapy for metastatic disease allowed - At least 1 week since prior hormonal therapy - No concurrent hormonal therapy Radiotherapy - See Disease Characteristics - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy, including radiotherapy for brain metastases Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StacyMoulder, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
MBCCOP - San Juan *Recruiting*
San Juan, , 00921-3201
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Gainesville *Recruiting*
Gainesville, Florida, 32608-1197
United States
Recruiting Dean McCarley 352-374-6016
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Veterans Affairs Medical Center - Indianapolis (Roudebush) *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Patrick Loehrer 317-554-0000
Burgess Health Center *Recruiting*
Onawa, Iowa, 51040
United States
Recruiting James Mailliard 712-423-2311
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Theodore Krontiris 626-301-8164
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Camilo Fadul 603-650-6312
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Drexel University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19102-1192
United States
Recruiting Pamela Crilley 215-762-8547
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting George Adams 612-625-2410
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting John Kirkwood 412-692-4724
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Veterans Affairs Medical Center - San Juan *Recruiting*
San Juan, , 00927-5800
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Maria Amarante Ribeiro 404-728-7680
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
Veterans Affairs Medical Center - Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Timothy Carlos 412-688-6248
Veterans Affairs Medical Center - Madison *Recruiting*
Madison, Wisconsin, 53705
United States
Recruiting Mark Albertini 608-262-7017
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5216
United States
Recruiting Harlan Pinto 650-725-9057
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Mohammed Raheem 414-384-2000
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto, California, 94304-1290
United States
Recruiting Harlan Pinto 650-493-5000 ext. 4948
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417-2399
United States
Recruiting Markus Gapany 612-725-2000 ext. 3459
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Veterans Affairs Medical Center - Omaha *Recruiting*
Omaha, Nebraska, 68105
United States
Recruiting James Mailliard 402-280-5274
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Veterans Affairs Medical Center - New York *Recruiting*
New York City, New York, 10010
United States
Recruiting Howard Hochster 212-652-1912
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
Veterans Affairs Medical Center - Miami *Recruiting*
Miami, Florida, 33125
United States
Recruiting Niramol Savaraj 305-324-3143
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
Veterans Affairs Medical Center - Brooklyn *Recruiting*
Brooklyn, New York, 11209
United States
Recruiting Andrea Wiesel Leaf 718-630-3691
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Veterans Affairs Medical Center - Tampa (Haley) *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Julie Kish 813-972-2000
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting William Wood 404-778-5180
Des Moines General Hospital *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-247-3121
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Robert Dreicer 216-445-4623
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus *Recruiting*
Nashville, Tennessee, 37212-2637
United States
Recruiting Kenneth Hande 615-327-4751
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
Additional Information:
Study ID Numbers: CDR0000350220; ECOG-E2103
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077376
Other Recurrent Breast Cancer Studies:
1. Chemotherapy in Treating Patients With Breast Cancer
2. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
3. Trastuzumab and Flavopiridol in Treating Patients With Metastatic Breast Cancer
4. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer
5. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
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Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer
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