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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081263 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia (CIN).
PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing cervical cancer in patients with CIN.
Condition | Intervention | Phase |
Cervical Cancer Precancerous/Nonmalignant Condition |
Drug: celecoxib Drug: placebo |
Phase II |
MedlinePlus related topics: | Cancer Cervical Cancer |
ChemIDplus related topics: | Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Randomized Double-Blind Phase II Trial of Celecoxib, a COX-2 Inhibitor, in the Treatment of Patients With Cervical Intraepithelial Neoplasia 2/3 or 3 (CIN 2/3 or CIN 3) |
Estimated Enrollment: | 100 |
Study Start Date: | June 2005 |
Arms | Assigned Interventions |
Arm I: Experimental
Patients receive oral celecoxib once daily for 14-18 weeks.
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Drug: celecoxib
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo once daily for 14-18 weeks.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to lesion size (covering ≤ ½ area of the cervix vs covering > ½ area of the cervix) and degree of cervical intraepithelial neoplasia (CIN) (CIN 2/3 vs CIN 3). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A maximum of 100 patients (50 per treatment arm) will be accrued for this study within 13 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3 by cervical biopsy 2-8 weeks prior to study entry
Pathology report must clearly state "CIN 2/3" or "3" OR "moderate-severe dysplasia," "moderate-severe dyskaryosis," "severe dysplasia," or "sever dyskaryosis."
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |||||
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting | ||||
Tucson, Arizona, United States, 85724-5024 | |||||
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 | |||||
United States, Arkansas | |||||
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting | ||||
Little Rock, Arkansas, United States, 72205 | |||||
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |||||
United States, Delaware | |||||
CCOP - Christiana Care Health Services | Recruiting | ||||
Newark, Delaware, United States, 19713 | |||||
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227 | |||||
United States, Florida | |||||
University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting | ||||
Miami, Florida, United States, 33136 | |||||
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com | |||||
United States, Illinois | |||||
CCOP - Carle Cancer Center | Recruiting | ||||
Urbana, Illinois, United States, 61801 | |||||
Contact: Clinical Trials Office - CCOP - Carle Cancer Center 800-446-5532 | |||||
Evanston Northwestern Healthcare - Evanston Hospital | Recruiting | ||||
Evanston, Illinois, United States, 60201-1781 | |||||
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev 847-570-1381 | |||||
United States, Kentucky | |||||
James Graham Brown Cancer Center at University of Louisville | Recruiting | ||||
Louisville, Kentucky, United States, 40292 | |||||
Contact: Edward G. Helm, MD, FACS, MHA 502-562-4158 | |||||
United States, Missouri | |||||
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting | ||||
Saint Louis, Missouri, United States, 63110 | |||||
Contact: David G. Mutch, MD 314-747-7222 | |||||
United States, Nevada | |||||
Women's Cancer Center - Lake Mead | Recruiting | ||||
Las Vegas, Nevada, United States, 89102 | |||||
Contact: Nick M. Spirtos, MD 408-866-3843 | |||||
United States, New Mexico | |||||
University of New Mexico Cancer Center | Recruiting | ||||
Albuquerque, New Mexico, United States, 87131-5636 | |||||
Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |||||
United States, North Carolina | |||||
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Recruiting | ||||
Pinehurst, North Carolina, United States, 28374 | |||||
Contact: Clinical Trials Office - FirstHealth Moore Regional Community 910-715-2200 | |||||
Gynecologic Oncology Network | Recruiting | ||||
Greenville, North Carolina, United States, 27834 | |||||
Contact: Howard D. Homesley, MD 252-756-5388 | |||||
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting | ||||
Chapel Hill, North Carolina, United States, 27599-7295 | |||||
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |||||
Wake Forest University Comprehensive Cancer Center | Recruiting | ||||
Winston-Salem, North Carolina, United States, 27157-1096 | |||||
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |||||
United States, Ohio | |||||
Case Comprehensive Cancer Center | Recruiting | ||||
Cleveland, Ohio, United States, 44106-5065 | |||||
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |||||
Charles M. Barrett Cancer Center at University Hospital | Recruiting | ||||
Cincinnati, Ohio, United States, 45267 | |||||
Contact: William E. Richards 513-584-3200 | |||||
Lake/University Ireland Cancer Center | Recruiting | ||||
Mentor, Ohio, United States, 44060 | |||||
Contact: Steven E. Waggoner, MD 216-844-5011 | |||||
United States, Oklahoma | |||||
Oklahoma University Cancer Institute | Recruiting | ||||
Oklahoma City, Oklahoma, United States, 73104 | |||||
Contact: Robert S. Mannel, MD 405-271-8787 | |||||
United States, South Dakota | |||||
Sanford Cancer Center at Sanford USD Medical Center | Recruiting | ||||
Sioux Falls, South Dakota, United States, 57117-5039 | |||||
Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |||||
United States, Texas | |||||
Brooke Army Medical Center | Recruiting | ||||
Fort Sam Houston, Texas, United States, 78234-6200 | |||||
Contact: Clinical Trials Office - Brooke Army Medical Center 210-916-4837 |
Gynecologic Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Janet S. Rader, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000360805, GOG-0207 |
First Received: | April 7, 2004 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00081263 |
Health Authority: | Unspecified |
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