- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00070057
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer
Studieoversikt
Status
Forhold
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.
SECONDARY OBJECTIVES:
I. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.
II. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.
III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.
IV. Identify collateral targets (COX-2-independent) of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
Arm II: Patients receive a higher dose of oral celecoxib as in arm I.
Arm III: Patients do not receive treatment.
All patients undergo definitive surgery.
PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Histologically confirmed invasive breast carcinoma
- Tumor at least 1 cm by radiologic estimate or physical exam
- No disease limited to ductal carcinoma in situ only
- Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center
Hormone receptor status:
- Not specified
- Female
Postmenopausal as defined by at least 1 of the following:
- No menstrual period within the past 12 months
- Prior bilateral oophorectomy
- No known liver disease
- No renal insufficiency
- No congestive heart failure
- No coronary artery disease
- No history of documented peptic ulcer disease
- No gastritis
- No medical condition that would preclude definitive surgery
- No allergy to NSAIDs or sulfa-containing drugs
No connective tissue diseases, including any of the following:
- Systemic lupus erythematosus
- Reynaud's disease
- Scleroderma
- More than 3 months since prior chemotherapy
- More than 2 weeks since prior hormone replacement therapy
- More than 2 weeks since prior tamoxifen
- More than 2 weeks since prior aromatase inhibitors
- More than 2 weeks since prior raloxifene
- More than 2 weeks since prior steroids
- More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
- More than 1 week since prior cyclooxygenase (COX)-2 inhibitors
- No concurrent warfarin
- No concurrent thiazide or loop diuretics
- No concurrent COX-2 inhibitors
- No concurrent NSAIDs
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I (celecoxib)
Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
|
Korrelative studier
Korrelative studier
Andre navn:
Å bli operert
Gis muntlig
Andre navn:
|
Eksperimentell: Arm II (high-dose celecoxib)
Patients receive a higher dose of oral celecoxib as in arm I.
|
Korrelative studier
Korrelative studier
Andre navn:
Å bli operert
Gis muntlig
Andre navn:
|
Aktiv komparator: Arm III (surgery)
Patients do not receive treatment.
All patients undergo surgery.
|
Korrelative studier
Korrelative studier
Andre navn:
Å bli operert
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in aromatase activity levels
Tidsramme: From baseline to post-surgery
|
From baseline to post-surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry
Tidsramme: From baseline to post-treatment
|
From baseline to post-treatment
|
Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens
Tidsramme: At post-treatment/surgery
|
At post-treatment/surgery
|
Effect of treatment vs. no treatment on gene expression (mRNA) profile by microarray, kinase activities (PI3, AKT and ERK1/2 MAP kinases) and PGE2 levels
Tidsramme: At post-treatment/surgery
|
At post-treatment/surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Elisa Port, Memorial Sloan Kettering Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Neoplasmer
- Neoplasmer etter nettsted
- Bryst sykdommer
- Brystneoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Syklooksygenase-hemmere
- Syklooksygenase 2-hemmere
- Celecoxib
Andre studie-ID-numre
- NCI-2012-01441 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- P30CA008748 (U.S. NIH-stipend/kontrakt)
- CDR0000329919
- MSKCC-03027 (Annen identifikator: Memorial Sloan-Kettering Cancer Center)
- N01-CN-35112 (Annen identifikator: DCP)
- N01CN35112 (Annet stipend/finansieringsnummer: US NIH Grant/Contract Award Number)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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