- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00084370
Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
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
Status
Intervention / Behandling
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
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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.
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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
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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
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Edward E. Partridge, MD, University of Alabama at Birmingham
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Cyclooxygenase 2-hæmmere
- Celecoxib
Andre undersøgelses-id-numre
- CDR0000352114
- UAB-0134
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Kliniske forsøg med oophorektomi
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityIkke rekrutterer endnuPræmenopausal brystkræft | Hormon-receptor-positiv brystkræft | Brystkræftpatienter med middel til høj risiko | Ovariefunktionssuppression kombineret med aromatasehæmmer eller Tamoxifen eller TorimefenKina