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Breast CancerPhase 2NCT00045591

Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer

A Phase 2 study testing celecoxib in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 74 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
celecoxib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
74 sitesUnited States
Study dates
Feb 2003to Jan 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36207

  • Veterans Affairs Medical Center - Asheville

    Asheville, North Carolina, 28805

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Cancer Institute of New Jersey at the Cooper University Hospital

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22902

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • NorthEast Oncology Associates - Concord

    Concord, North Carolina, 28025

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    East Syracuse, New York, 13057

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Cape Fear Valley Medical Center

    Fayetteville, North Carolina, 28302-2000

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana, 46885-5099

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • Memorial Regional Cancer Center at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28503-1678

  • Lagrange Oncology Associates

    La Grange, Illinois, 60525

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Veterans Affairs Medical Center - Las Vegas

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615-7828

  • Comprehensive Cancer Center at Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • West Suburban Center for Cancer Care

    River Forest, Illinois, 60305

  • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke

    Roanoke, Virginia, 24014

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Veterans Affairs Medical Center - Washington, DC

    Washington D.C., District of Columbia, 20422

  • Zimmer Cancer Center at New Hanover Regional Medical Center

    Wilmington, North Carolina, 28402-9025

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions
Breast Cancer
Being tested
celecoxib
Keywords
recurrent breast cancer, stage IV breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00045591
Study groupRoleWhat they receive
Celecoxib 100 mgExperimentalNot described
Receives: Drug: celecoxib
Celecoxib 400 mgExperimentalNot described
Receives: Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionAug 2005
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045591
Sponsor's protocol ID
CALGB-40105
Other IDs
U10CA031946, CALGB-40105, CDR0000256905
Status last verified
Jan 2017
First submitted
6 Sep 2002
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing celecoxib in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 74 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 28 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045591.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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