Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
NCT ID: NCT00045591
Last Updated: 2017-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
39 participants
INTERVENTIONAL
2003-02-28
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
NCT00075673
Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer
NCT00005963
Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
NCT00003540
Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
NCT00897702
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
NCT00051103
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Compare the progression-free survival of women with metastatic or recurrent breast cancer treated with 2 dose levels of celecoxib.
Secondary
* 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 every 3 months for 1 year and then every 6 months for up to 4 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Celecoxib 100 mg
celecoxib
100 mg PO bid
Celecoxib 400 mg
Celecoxib
400 mg PO bid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
celecoxib
100 mg PO bid
Celecoxib
400 mg PO bid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles L. Shapiro, MD
Role: STUDY_CHAIR
Ohio State University Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Lagrange Oncology Associates
La Grange, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CALGB-40105
Identifier Type: -
Identifier Source: secondary_id
CDR0000256905
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-40105
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.