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Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy

21. august 2013 opdateret af: Edward Partridge, University of Alabama at Birmingham

Molecular Alterations in Human Ovarian Epithelium Induced by Chemopreventive Agents in Patients at Elevated Inherited Risk of Ovarian Cancer: A Controlled Pilot Study in Ovarian Cancer Chemoprevention

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib before prophylactic oophorectomy may be an effective way to prevent the development of ovarian epithelial cancer.

PURPOSE: A controlled pilot trial to study the effectiveness of celecoxib in preventing cancer in patients at high-risk for ovarian epithelial cancer who are undergoing prophylactic oophorectomy.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Compare histologic and molecular alterations in tissue biomarkers of patients at high risk for ovarian cancer treated with celecoxib followed by prophylactic oophorectomy vs prophylactic oophorectomy only.

Secondary

  • Compare alterations in gene expression pattern in patients treated with these regimens.

OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups.

  • Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
  • Group II: Patients undergo immediate prophylactic oophorectomy.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • At high risk for ovarian cancer and meets criteria for 1 of the following:

    • Family history of at least 2 ovarian** or breast cancers* among the patient and first- or second-degree relatives in the same lineage

      • Multiple primary cancers in the same person may fulfill this requirement
    • Ashkenazi Jewish ethnicity AND 1 first-degree or 2 second-degree relatives with breast* or ovarian** cancer
    • Ashkenazi Jewish ethnicity AND had prior breast cancer*
    • BRCA1/BRCA2 mutation probability > 20% by BRCAPRO
    • Positive for BRCA1 or BRCA2 mutation
    • First- or second-degree relative with a BRCA1/BRCA2 mutation NOTE: *At least 1 breast cancer must be premenopausal (diagnosed at age 50 or under if menopausal status unknown); ductal carcinoma in situ qualifies as breast cancer

NOTE: **In relatives, only ovarian epithelial cancer, fallopian tube cancer, and primary papillary serous cancer qualifies as ovarian cancer

  • No prior or concurrent ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum

    • No clinical evidence of ovarian cancer by physical examination, CA 125 evaluation, and pelvic ultrasound

PATIENT CHARACTERISTICS:

Age

  • 19 and over

Performance status

  • GOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 3,000/mm^3
  • Granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • No hemophilia or other bleeding disorder
  • No serious anemia

Hepatic

  • Transaminases normal
  • Bilirubin normal

Renal

  • Creatinine clearance > 80 mL/min OR
  • Creatinine < 2.0 mg/dL

Pulmonary

  • No emphysema

Other

  • Not pregnant or nursing
  • No psychiatric or psychological condition that would preclude giving informed consent
  • No concurrent untreated malignancy except nonmelanoma skin cancer
  • No other medical condition that would preclude blood draws (e.g., chronic infectious disease)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 3 months since prior adjuvant chemotherapy

Endocrine therapy

  • Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed

Radiotherapy

  • More than 3 months since prior adjuvant radiotherapy

Surgery

  • More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
  • No prior oophorectomy

Other

  • More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy
  • No concurrent participation in other ovarian cancer early detection clinical trials

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
Eksperimentel: Group II
Group II: Patients undergo immediate prophylactic oophorectomy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Alteration in the histologic and molecular alterations in tissue biomarkers between patients at high risk for ovarian cancer treated with Celecoxib and treated without Celecoxib both having prophylactic oophorectomy.
Tidsramme: baseline (day of surgery) and 2 years
baseline (day of surgery) and 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Alteration in gene expression between group I and group II
Tidsramme: from baseline (surgery) to 2 years
from baseline (surgery) to 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Edward E. Partridge, MD, University of Alabama at Birmingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2002

Primær færdiggørelse (Faktiske)

1. marts 2005

Studieafslutning (Faktiske)

1. marts 2005

Datoer for studieregistrering

Først indsendt

10. juni 2004

Først indsendt, der opfyldte QC-kriterier

10. juni 2004

Først opslået (Skøn)

11. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2013

Sidst verificeret

1. august 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med oophorektomi

3
Abonner