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

NCT00084370 | Withdrawn DMC

• 2 other identifiers: CDR0000352114UAB-0134
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

brca1 Mutation Carrier; brca2 Mutation Carrier; Ovarian Cancer

Keywords

ovarian epithelial cancer; BRCA1 mutation carrier; BRCA2 mutation carrier

Outcome Measures

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.

  baseline (day of surgery) and 2 years

Secondary Outcomes (1)

• Alteration in gene expression between group I and group II

  from baseline (surgery) to 2 years

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: celecoxib; Procedure: oophorectomy

Group II

EXPERIMENTAL

Group II: Patients undergo immediate prophylactic oophorectomy.

Procedure: oophorectomy

Interventions

celecoxib DRUG

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

Group 1

oophorectomy PROCEDURE

Group 1; Group II

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Celecoxib; Ovariectomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures

Study Officials

• Edward E. Partridge, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: June 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

US (1)