Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design
Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
Sponsors
Source
Alliance for Clinical Trials in Oncology
Oversight Info
Has Dmc
Yes
Brief 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.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib
in treating women who have metastatic or recurrent breast cancer
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.
Overall Status
Terminated
Start Date
2003-02-01
Completion Date
2010-01-01
Primary Completion Date
2005-08-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Progression free survival |
28 months |
Enrollment
39
Condition
Intervention
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
Gender
Female
Minimum Age
18 Years
Maximum Age
120 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
Charles L. Shapiro, MD |
Study Chair |
Ohio State University Comprehensive Cancer Center |
Location
Facility |
Northeast Alabama Regional Medical Center Anniston Alabama 36207 United States |
Rebecca and John Moores UCSD Cancer Center La Jolla California 92093-0658 United States |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles California 90048 United States |
Naval Medical Center - San Diego San Diego California 92134-3202 United States |
Veterans Affairs Medical Center - San Diego San Diego California 92161 United States |
UCSF Comprehensive Cancer Center San Francisco California 94115 United States |
Veterans Affairs Medical Center - San Francisco San Francisco California 94121 United States |
CCOP - Christiana Care Health Services Newark Delaware 19713 United States |
Lombardi Cancer Center at Georgetown University Medical Center Washington District of Columbia 20007 United States |
Walter Reed Army Medical Center Washington District of Columbia 20307-5001 United States |
Veterans Affairs Medical Center - Washington, DC Washington District of Columbia 20422 United States |
Broward General Medical Center Fort Lauderdale Florida 33316 United States |
Memorial Regional Cancer Center at Memorial Regional Hospital Hollywood Florida 33021 United States |
CCOP - Mount Sinai Medical Center Miami Beach Florida 33140 United States |
MBCCOP - University of Illinois at Chicago Chicago Illinois 60612 United States |
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois 60612 United States |
University of Chicago Cancer Research Center Chicago Illinois 60637-1470 United States |
Lagrange Oncology Associates La Grange Illinois 60525 United States |
CCOP - Illinois Oncology Research Association Peoria Illinois 61615-7828 United States |
West Suburban Center for Cancer Care River Forest Illinois 60305 United States |
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne Indiana 46885-5099 United States |
CCOP - Northern Indiana CR Consortium South Bend Indiana 46601 United States |
Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa 52242-1009 United States |
Baptist Hospital East - Louisville Louisville Kentucky 40207 United States |
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland 21201 United States |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts 02115 United States |
UMASS Memorial Cancer Center - University Campus Worcester Massachusetts 01655 United States |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph Michigan 49085 United States |
Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota 55417 United States |
University of Minnesota Cancer Center Minneapolis Minnesota 55455 United States |
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri 65201 United States |
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri 65203 United States |
CCOP - Kansas City Kansas City Missouri 64131 United States |
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis Missouri 63110 United States |
Missouri Baptist Cancer Center Saint Louis Missouri 63131 United States |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska 68198-7680 United States |
CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada 89106 United States |
Veterans Affairs Medical Center - Las Vegas Las Vegas Nevada 89106 United States |
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett New Hampshire 03106 United States |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756-0002 United States |
Cancer Institute of New Jersey at the Cooper University Hospital Camden New Jersey 08103 United States |
Veterans Affairs Medical Center - Buffalo Buffalo New York 14215 United States |
Roswell Park Cancer Institute Buffalo New York 14263-0001 United States |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. East Syracuse New York 13057 United States |
Elmhurst Hospital Center Elmhurst New York 11373 United States |
Queens Cancer Center of Queens Hospital Jamaica New York 11432 United States |
CCOP - North Shore University Hospital Manhasset New York 11030 United States |
North Shore University Hospital Manhasset New York 11030 United States |
Memorial Sloan-Kettering Cancer Center New York New York 10021 United States |
New York Weill Cornell Cancer Center at Cornell University New York New York 10021 United States |
Mount Sinai Medical Center New York New York 10029 United States |
SUNY Upstate Medical University Hospital Syracuse New York 13210 United States |
Veterans Affairs Medical Center - Syracuse Syracuse New York 13210 United States |
Veterans Affairs Medical Center - Asheville Asheville North Carolina 28805 United States |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina 27599-7295 United States |
NorthEast Oncology Associates - Concord Concord North Carolina 28025 United States |
Veterans Affairs Medical Center - Durham Durham North Carolina 27705 United States |
Duke Comprehensive Cancer Center Durham North Carolina 27710 United States |
Cape Fear Valley Medical Center Fayetteville North Carolina 28302-2000 United States |
CCOP - Southeast Cancer Control Consortium Goldsboro North Carolina 27534-9479 United States |
Lenoir Memorial Cancer Center Kinston North Carolina 28503-1678 United States |
Comprehensive Cancer Center at Moore Regional Hospital Pinehurst North Carolina 28374 United States |
Zimmer Cancer Center at New Hanover Regional Medical Center Wilmington North Carolina 28402-9025 United States |
Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina 27157-1082 United States |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus Ohio 43210-1240 United States |
Oklahoma University Medical Center Oklahoma City Oklahoma 73104 United States |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania 15224 United States |
Lifespan: The Miriam Hospital Providence Rhode Island 02906 United States |
Vermont Cancer Center at University of Vermont Burlington Vermont 05401-3498 United States |
Martha Jefferson Hospital Charlottesville Virginia 22902 United States |
Virginia Oncology Associates - Norfolk Norfolk Virginia 23502 United States |
MBCCOP - Massey Cancer Center Richmond Virginia 23298-0037 United States |
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke Roanoke Virginia 24014 United States |
St. Mary's Medical Center Huntington West Virginia 25701 United States |
Location Countries
Country
United States
Verification Date
2017-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
U10CA031946
CALGB-40105
CDR0000256905
Number Of Arms
2
Intervention Browse
Mesh Term
Celecoxib
Arm Group
Arm Group Label
Celecoxib 100 mg
Arm Group Type
Experimental
Arm Group Label
Celecoxib 400 mg
Arm Group Type
Experimental
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Study First Submitted
September 6, 2002
Study First Submitted Qc
January 26, 2003
Study First Posted
January 27, 2003
Last Update Submitted
January 9, 2017
Last Update Submitted Qc
January 9, 2017
Last Update Posted
January 11, 2017
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.