Celecoxib in Preventing Cancer in Patients at High Risk for Ovarian Epithelial Cancer Who Are Undergoing Prophylactic Oophorectomy
This study has been withdrawn prior to enrollment.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Partridge, University of Alabama at Birmingham
First received: June 10, 2004
Last updated: August 21, 2013
Last verified: August 2013
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.
brca1 Mutation Carrier
brca2 Mutation Carrier
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||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
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. [ Time Frame: baseline (day of surgery) and 2 years ]
Secondary Outcome Measures:
- Alteration in gene expression between group I and group II [ Time Frame: from baseline (surgery) to 2 years ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2005 (Final data collection date for primary outcome measure)
Experimental: Group 1
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.
Patients receive ora celecoxib twice daily for 3 months prior to prophylactic oophorectomy.
Experimental: Group II
Group II: Patients undergo immediate prophylactic oophorectomy.
- 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.
- 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.
|Ages Eligible for Study:
||19 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
NOTE: **In relatives, only ovarian epithelial cancer, fallopian tube cancer, and primary papillary serous cancer qualifies as ovarian cancer
- 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
- Transaminases normal
- Bilirubin normal
- Creatinine clearance > 80 mL/min OR
- Creatinine < 2.0 mg/dL
- 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:
- More than 3 months since prior adjuvant chemotherapy
- Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed
- More than 3 months since prior adjuvant radiotherapy
- More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
- No prior oophorectomy
- More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy
- No concurrent participation in other ovarian cancer early detection clinical trials
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084370
|University of Alabama at Birmingham Comprehensive Cancer Center
|Birmingham, Alabama, United States, 35294-3300 |
University of Alabama at Birmingham
National Cancer Institute (NCI)
||Edward E. Partridge, MD
||University of Alabama at Birmingham
||Edward Partridge, Principal Investigator, University of Alabama at Birmingham
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 10, 2004
||August 21, 2013
Keywords provided by Edward Partridge, University of Alabama at Birmingham:
ovarian epithelial cancer
BRCA1 mutation carrier
BRCA2 mutation carrier
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 23, 2017
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Cyclooxygenase 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs