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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00084370
• Other study ID #: CDR0000352114
• Secondary ID: UAB-0134
• Status: Withdrawn
• Phase: N/A
• First received: June 10, 2004
• Last updated: August 21, 2013
• Start date: June 2002
• Est. completion date: March 2005

Study information

• Verified date: August 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• brca1 Mutation Carrier
• brca2 Mutation Carrier
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Procedure:
• oophorectomy

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Alteration in gene expression between group I and group II		from baseline (surgery) to 2 years	No