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

Sponsoren

Hauptsponsor: Alliance for Clinical Trials in Oncology

Mitarbeiter: National Cancer Institute (NCI)

Quelle Alliance for Clinical Trials in Oncology
Kurze Zusammenfassung

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

detaillierte Beschreibung

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.

Gesamtstatus Terminated
Anfangsdatum February 2003
Fertigstellungstermin January 2010
Primäres Abschlussdatum August 2005
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Progression free survival 28 months
Einschreibung 39
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: celecoxib

Beschreibung: 100 mg PO bid

Armgruppenetikett: Celecoxib 100 mg

Interventionsart: Drug

Interventionsname: Celecoxib

Beschreibung: 400 mg PO bid

Armgruppenetikett: Celecoxib 400 mg

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: Female

Mindestalter: 18 Years

Maximales Alter: 120 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Charles L. Shapiro, MD Study Chair Ohio State University Comprehensive Cancer Center
Ort
Einrichtung:
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
Standort Länder

United States

Überprüfungsdatum

January 2017

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Celecoxib 100 mg

Art: Experimental

Etikette: Celecoxib 400 mg

Art: Experimental

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Triple (Participant, Care Provider, Investigator)

Quelle: ClinicalTrials.gov