Clinical trial NCT00084370: Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: brca1 Mutation Carrier
brca2 Mutation Carrier
Ovarian Cancer
Keywords: ovarian epithelial cancer
BRCA1 mutation carrier
BRCA2 mutation carrier
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: baseline (day of surgery) and 2 years
Secondary outcomes:
measure: Alteration in gene expression between group I and group II
timeFrame: from baseline (surgery) to 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Edward E. Partridge, MD
role: PRINCIPAL_INVESTIGATOR
References: