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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


Phase 2
19 Years
N/A
Open (Enrolling)
Female
brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer

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Trial Information

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


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.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment group) will be accrued for this
study within 2 years.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Edward E. Partridge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000352114

NCT ID:

NCT00084370

Start Date:

June 2002

Completion Date:

Related Keywords:

  • brca1 Mutation Carrier
  • brca2 Mutation Carrier
  • Ovarian Cancer
  • ovarian epithelial cancer
  • BRCA1 mutation carrier
  • BRCA2 mutation carrier
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300