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WithdrawnNCT00084370Updated Aug 22, 2013

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

An interventional study of celecoxib and oophorectomy in brca1 Mutation Carrier, brca2 Mutation Carrier and Ovarian Cancer, sponsored by University of Alabama at Birmingham. Withdrawn at 1 site in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-08-22.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
19 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • brca1 Mutation Carrier
  • brca2 Mutation Carrier
  • Ovarian Cancer

Keywords

  • ovarian epithelial cancer
  • BRCA1 mutation carrier
  • BRCA2 mutation carrier
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

Browse Ovarian Neoplasms studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,397 studies on the registry; 285 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Group 1

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

    Drug: celecoxib · Procedure: oophorectomy

  • Experimental
    Group II

    Group II: Patients undergo immediate prophylactic oophorectomy.

    Procedure: oophorectomy

Interventions

  • Drugcelecoxib

    Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.

  • Procedureoophorectomy
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline (day of surgery) and 2 years

Secondary outcomes

  1. Alteration in gene expression between group I and group II

    Time frame: from baseline (surgery) to 2 years

07

Study locations

1 site
  • University of Alabama at Birmingham Comprehensive Cancer Center
    Birmingham, Alabama 35294-3300, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00084370
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
Responsible party
Edward Partridge (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Jun 11, 2004
Start date
Jun 2002
Primary completion
Mar 2005
Completion
Mar 2005
Last update
Aug 22, 2013

Study contacts

Edward E. Partridge, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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