brca1 Mutation CarrierNCT00084370
Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
A study testing celecoxib and oophorectomy in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer
- What is being tested?
- celecoxib and oophorectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Mar 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
About this study
Official title: 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.
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.
- Being tested
- celecoxib, oophorectomy
- Keywords
- ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
oophorectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy. Receives: Drug: celecoxib; Procedure: oophorectomy |
| Group II | Experimental | Group II: Patients undergo immediate prophylactic oophorectomy. Receives: Procedure: oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (day of surgery) and 2 years
Secondary outcomes (1)
Alteration in gene expression between group I and group II
Measured: from baseline (surgery) to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startJun 2002
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for brca1 Mutation CarrierStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Edward Partridge, University of Alabama at Birmingham
- Investigators
- Edward E. Partridge, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084370
- Sponsor's protocol ID
- CDR0000352114
- Other IDs
- UAB-0134
- Status last verified
- Aug 2013
- First submitted
- 10 Jun 2004
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00084370
- Acronym / sponsor ID
- CDR0000352114
- Keywords
- ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 11 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: celecoxib, Procedure: oophorectomyGroup I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy. |
| Group II | Experimental | Procedure: oophorectomyGroup II: Patients undergo immediate prophylactic oophorectomy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxibPatients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy. | Drug | Group 1 |
| oophorectomy | Procedure or surgery | Group 1, Group II |
Primary outcome
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
1 secondary outcome
Alteration in gene expression between group I and group II
Time frame: from baseline (surgery) to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward E. Partridge, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing celecoxib and oophorectomy in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2013.