Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
Breast Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer
Eligibility 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 Bone disease alone allowed 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 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 6 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
Sites / Locations
- Northeast Alabama Regional Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Naval Medical Center - San Diego
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Cancer Center at Memorial Regional Hospital
- CCOP - Mount Sinai Medical Center
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Lagrange Oncology Associates
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Holden Comprehensive Cancer Center at University of Iowa
- Baptist Hospital East - Louisville
- Greenebaum Cancer Center at University of Maryland Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- UMASS Memorial Cancer Center - University Campus
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- CCOP - Kansas City
- Siteman Cancer Center at Barnes-Jewish Hospital
- Missouri Baptist Cancer Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- New Hampshire Oncology-Hematology, PA - Hooksett
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cancer Institute of New Jersey at the Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Elmhurst Hospital Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- NorthEast Oncology Associates - Concord
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Medical Center
- CCOP - Southeast Cancer Control Consortium
- Lenoir Memorial Cancer Center
- Comprehensive Cancer Center at Moore Regional Hospital
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Oklahoma University Medical Center
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Lifespan: The Miriam Hospital
- Vermont Cancer Center at University of Vermont
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
- St. Mary's Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Celecoxib 100 mg
Celecoxib 400 mg