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

Primary Purpose

brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
celecoxib
oophorectomy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for brca1 Mutation Carrier focused on measuring ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group II

Arm Description

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

Group II: Patients undergo immediate prophylactic oophorectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Alteration in gene expression between group I and group II

Full Information

First Posted
June 10, 2004
Last Updated
August 21, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00084370
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Study Start Date
June 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer
Keywords
ovarian epithelial cancer, BRCA1 mutation carrier, BRCA2 mutation carrier

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Arm Title
Group II
Arm Type
Experimental
Arm Description
Group II: Patients undergo immediate prophylactic oophorectomy.
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
Intervention Type
Procedure
Intervention Name(s)
oophorectomy
Primary Outcome Measure Information:
Title
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.
Time Frame
baseline (day of surgery) and 2 years
Secondary Outcome Measure Information:
Title
Alteration in gene expression between group I and group II
Time Frame
from baseline (surgery) to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward E. Partridge, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States

12. IPD Sharing Statement

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

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