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Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer Clinical research trials and Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer. Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer  Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer
Details: OBJECTIVES: - Compare the efficacy of 2 dose levels of celecoxib, in terms of 6-month progression-free survival, in women with metastatic or recurrent breast cancer. - Compare the side effects of the 2 dose levels of this drug in these patients. - Compare the overall survival of patients treated with the 2 dose levels of this drug. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to disease status at study entry (complete response vs partial response vs stable) and prior metastatic/recurrent chemotherapy regimens (1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral high-dose celecoxib twice daily. - Arm II: Patients receive oral low-dose celecoxib twice daily. In both arms, treatment continues until first disease progression. At disease progression, treatment assignment is unblinded and treatment may continue at the treating physician's discretion. Patients initially randomized to the low-dose arm may either continue on that dosage or crossover to the high-dose arm. Patients initially randomized to the high-dose arm may continue on that dosage. Treatment after disease progression may continue for up to 12 months. Patients are followed for up to 5 years. PROJECTED ACCRUAL: A total of 132 patients (88 in the high-dose arm and 44 in the low-dose arm) will be accrued for this study within 22 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive breast cancer - Metastatic or recurrent disease documented by physical or radiographic examination - Isolated recurrence of breast cancer not considered eligible - At least 4 prior courses (or 4 months) of chemotherapy resulting in stable disease, partial response, or complete response - Treated brain metastases allowed provided all of the following conditions are met: - Palliation achieved without evidence of progression for at least 3 months after completion of radiotherapy and/or surgical treatment - At least 30 days since prior dexamethasone or other corticosteroids - Documentation of another site of metastatic disease (in addition to brain metastases) - Measurable or evaluable disease - No bone marrow disease only - Pleural or peritoneal effusion as only manifestation of disease allowed if palliated by prior chemotherapy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - CTC (ECOG) 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST or ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) - Albumin at least 3.0 g/dL Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other active malignancy within the past 2 years except nonmelanoma skin cancer - No active peptic ulcer disease - No known hypersensitivity to sulfonamides, aspirin, or other NSAIDs, including celecoxib PRIOR CONCURRENT THERAPY: Biologic therapy - Concurrent trastuzumab (Herceptin) allowed if initiated at least 3 months prior to study entry Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No more than 2 prior chemotherapy regimens for recurrent or metastatic disease Endocrine therapy - See Disease Characteristics - Prior hormonal therapy for metastatic disease allowed - No concurrent hormonal therapy except hormones for noncancer-related conditions (e.g., insulin for diabetes) Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - Prior radiotherapy to the breast and for metastatic disease allowed - No concurrent palliative radiotherapy Surgery - See Disease Characteristics Other - Prior adjuvant therapy for metastatic disease allowed - Concurrent bisphosphonates allowed - Concurrent low-dose aspirin (no greater than 325 mg/day) is allowed - No other concurrent therapy with celecoxib or other nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., rofecoxib, aspirin, choline magnesium trisalicylate, ibuprofen, naproxen, etodolac, oxaprozin, diflunisal, nabumetone, or tolmetin) - No concurrent fluconazole
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesShapiro, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Gerald Clamon 319-356-1932
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Elmhurst Hospital Center *Recruiting*
Elmhurst, New York, 11373
United States
Recruiting Vladimir Benisovich 718-334-3723
Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting William Patterson 573-882-6163
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Edward Gelmann 202-444-7303
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Stephen Seagren 858-657-7020
Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston, North Carolina, 28503-1678
United States
Recruiting Peter Watson 919-559-2200 Ext. 201
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Pankaj Bhargava 508-856-6884
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Richard Shadduck 412-578-4355
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Michael Perry 573-882-4979
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Lewis Silverman 212-241-5520
Missouri Baptist Cancer Center *Recruiting*
St. Louis, Missouri, 63131
United States
Recruiting Alan Lyss 314-996-5514
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Bruce Peterson 612-624-5631
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting George Canellos 617-632-3470
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Debasish Tripathy 214-648-5113
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Hyman Muss 802-847-3827
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Clara Bloomfield 614-293-7518
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Alan Lefor 310-423-5874
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Rogerio Lilenbaum 305-674-2625
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting Patricia Cornett 415-221-4810 ext. 3423
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Lifespan: The Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting William Sikov 401-793-7151
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Vicki Morrison 612-725-2000 ext. 4135
Veterans Affairs Medical Center - Durham *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michael Kelley 919-286-0411
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Thomas Shea 919-966-7746
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction, Vermont, 05009
United States
Recruiting Joseph O'Donnell 802-295-9363 ext. 5480
University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Enrique Velez-Garcia 787-754-0101 Ext.2020
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Alan Venook 800-888-8664
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Marc Ernstoff 603-650-5534
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Daniel Budman 516-562-8958
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Lynn Steinbrenner 716-862-3191
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Chau Dang 212-639-7940
Barnes-Jewish Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-747-3000
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-476-7461
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting Joseph Drabick 202-782-6751
Green Mountain Oncology Group *Recruiting*
Bennington, Vermont, 05201
United States
Recruiting L. Maurer 802-442-1290
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-464-8200
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Jeffrey Crawford 919-684-5195
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8915
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Additional Information:
Study ID Numbers: CDR0000256905; CALGB-40105
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045591
Other Recurrent Breast Cancer Studies:
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2. Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
3. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
4. Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer
5. Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
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Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
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