- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045591
Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their 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: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer
Study Overview
Detailed Description
OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Alabama
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Anniston, Alabama, United States, 36207
- Northeast Alabama Regional Medical Center
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California
-
La Jolla, California, United States, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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San Diego, California, United States, 92161
- Veterans Affairs Medical Center - San Diego
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San Diego, California, United States, 92134-3202
- Naval Medical Center - San Diego
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San Francisco, California, United States, 94115
- UCSF Comprehensive Cancer Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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Delaware
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, United States, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward General Medical Center
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Hollywood, Florida, United States, 33021
- Memorial Regional Cancer Center at Memorial Regional Hospital
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60612
- MBCCOP - University of Illinois at Chicago
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La Grange, Illinois, United States, 60525
- LaGrange Oncology Associates
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Peoria, Illinois, United States, 61615-7828
- CCOP - Illinois Oncology Research Association
-
River Forest, Illinois, United States, 60305
- West Suburban Center for Cancer Care
-
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Indiana
-
Fort Wayne, Indiana, United States, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
-
South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East - Louisville
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Maryland
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Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Saint Joseph, Michigan, United States, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, United States, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198-7680
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, United States, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Hooksett, New Hampshire, United States, 03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, United States, 08103
- Cancer Institute of New Jersey at the Cooper University Hospital
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
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East Syracuse, New York, United States, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Elmhurst, New York, United States, 11373
- Elmhurst Hospital Center
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Jamaica, New York, United States, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Asheville, North Carolina, United States, 28805
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, United States, 28025
- NorthEast Oncology Associates - Concord
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Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, United States, 28302-2000
- Cape Fear Valley Medical Center
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Goldsboro, North Carolina, United States, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Kinston, North Carolina, United States, 28503-1678
- Lenoir Memorial Cancer Center
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Pinehurst, North Carolina, United States, 28374
- Comprehensive Cancer Center at Moore Regional Hospital
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Wilmington, North Carolina, United States, 28402-9025
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma University Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Lifespan: The Miriam Hospital
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Vermont
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, United States, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, United States, 24014
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
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West Virginia
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Huntington, West Virginia, United States, 25701
- St. Mary's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Celecoxib 100 mg
|
100 mg PO bid
|
Experimental: Celecoxib 400 mg
|
400 mg PO bid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival
Time Frame: 28 months
|
28 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- CALGB-40105
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000256905 (Registry Identifier: NCI Physician Data Query)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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