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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00084370

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
brca1 Mutation Carrier brca2 Mutation Carrier Ovarian Cancer	Drug: celecoxib Procedure: oophorectomy	N/A

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

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Mar 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.	Drug: celecoxib Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy. Procedure: oophorectomy
Experimental: Group II Group II: Patients undergo immediate prophylactic oophorectomy.	Procedure: oophorectomy

Arm

Intervention/Treatment

Experimental: Group 1

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

Drug: celecoxib

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

Procedure: oophorectomy

Experimental: Group II

Group II: Patients undergo immediate prophylactic oophorectomy.

Procedure: oophorectomy

Outcome Measures

Primary Outcome Measures

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. [baseline (day of surgery) and 2 years]

Secondary Outcome Measures

Alteration in gene expression between group I and group II [from baseline (surgery) to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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