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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Martha Jefferson HospitalCharlottesville, Virginia  22901
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
NorthEast Oncology Associates - ConcordConcord, North Carolina  28025
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cape Fear Valley Medical CenterFayetteville, North Carolina  28302-2000
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Comprehensive Cancer Center at Moore Regional HospitalPinehurst, North Carolina  28374
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
Memorial Regional Cancer Center at Memorial Regional HospitalHollywood, Florida  33021
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Lagrange Oncology AssociatesLa Grange, Illinois  60525