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

NCT ID: NCT00084370

Last Updated: 2013-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2005-03-31

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.

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.

Conditions

brca1 Mutation Carrier; brca2 Mutation Carrier; Ovarian Cancer

Keywords

ovarian epithelial cancer; BRCA1 mutation carrier; BRCA2 mutation carrier

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

celecoxib

Intervention Type: DRUG

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

oophorectomy

Intervention Type: PROCEDURE

Group II

Group II: Patients undergo immediate prophylactic oophorectomy.

Group Type: EXPERIMENTAL

oophorectomy

Intervention Type: PROCEDURE

Interventions

celecoxib

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

Intervention Type: DRUG

oophorectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Edward Partridge

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward E. Partridge, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-0134

Identifier Type: -

Identifier Source: secondary_id

CDR0000352114

Identifier Type: -

Identifier Source: org_study_id