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Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

28 months

Safety Issue:

No

Principal Investigator

Charles L. Shapiro, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000256905

NCT ID:

NCT00045591

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Martha Jefferson Hospital Charlottesville, Virginia  22901
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University Hospital Camden, New Jersey  08103-1489
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Naval Medical Center - San Diego San Diego, California  92134-3202
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
West Suburban Center for Cancer Care River Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett, New Hampshire  03106
NorthEast Oncology Associates - Concord Concord, North Carolina  28025
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
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Cape Fear Valley Medical Center Fayetteville, North Carolina  28302-2000
Lenoir Memorial Cancer Center Kinston, North Carolina  28503-1678
Comprehensive Cancer Center at Moore Regional Hospital Pinehurst, North Carolina  28374
Zimmer Cancer Center at New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
Memorial Regional Cancer Center at Memorial Regional Hospital Hollywood, Florida  33021
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224-1791
Lagrange Oncology Associates La Grange, Illinois  60525