Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
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 3)
4 other identifiers
interventional
130
1 country
43
Brief Summary
This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2004
CompletedFirst Posted
Study publicly available on registry
April 8, 2004
CompletedStudy Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedResults Posted
Study results publicly available
September 15, 2017
CompletedSeptember 15, 2017
August 1, 2017
7.3 years
April 7, 2004
November 29, 2016
September 13, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Histologic Regression
Whether or not patients with CIN 2/3 or CIN 3 upon entry experience a complete remission (or partial regression to CIN 1) in the post-treatment excisional biopsy.
Post treatment evaluation was done 14 to 18 weeks after treatment randomization
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Number of participants with a grade of 3 or higher during the treatment period.
Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Other Outcomes (12)
To Examine the Association of Histologic Response in COX-2 in Tissue
Up to 18 weeks
To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment
Up to 18 weeks
HPV Viral Load Before and After Treatment
Up to 18 weeks
- +9 more other outcomes
Study Arms (2)
Arm I (celecoxib)
EXPERIMENTALPatients receive oral celecoxib once daily for 14-18 weeks.
Arm II (placebo)
PLACEBO COMPARATORPatients receive oral placebo once daily for 14-18 weeks.
Interventions
Given orally
Eligibility Criteria
You may qualify if:
- Patients must have histologically proven CIN 2/3 or CIN 3 diagnosed by cervical biopsy between 2 and 8 weeks prior to enrollment
- For a patient to be eligible, the pathology report must clearly state "CIN 2/3" or "CIN 3" or must state "moderate-severe dysplasia", "moderate-severe dyskaryosis," "severe dysplasia," or "severe dyskaryosis;" patients with a diagnosis of CIN 2 alone or moderate dysplasia or dyskaryosis alone are not eligible for this study (3/26/2007)
- Patients must have a satisfactory (readable, good quality) colposcopic evaluation at least 14 days after diagnostic biopsy
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients must have colposcopically visible cervical lesion at entry consistent with biopsy
- Patients must have a negative urine pregnancy test; women of childbearing potential must practice an acceptable form of contraception (e.g. intrauterine device, contraceptive pills, diaphragm, condoms)
- Patients must have a GOG Performance Status of 0, 1, or 2
- Patients must agree to refrain from using non-steroidal anti-inflammatory drugs (NSAIDS) and aspirin during the time they are taking the study medication
- Patients must be good candidates for delayed treatment of their CIN, i.e. they must be reliable to return for follow-up and provide a combination of at least three phone numbers or addresses for contact
- Hemoglobin (HgB) greater than 11.0g/dl
- White blood cell (WBC) count greater than 3000/mcl
- Platelet count greater than 125,000/mcl (3/26/2007)
- Creatinine less than or equal to 1.5 x upper limit normal (ULN)
- Total bilirubin less than or equal to 1.5 x ULN excluding Gilbert's disease
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.0 x ULN
You may not qualify if:
- Patients who are pregnant or lactating
- Patients with cytologic or biopsy evidence of endocervical dysplasia or invasive cancer
- Patients with undiagnosed abnormal vaginal bleeding
- Patients who have previously taken celecoxib or any other COX-2 inhibitor at a frequency of greater than 3 times per week within 2 months (60 days) prior to randomization; patients can use Naproxen without restriction (6/23/2008)
- Patients with a known immunocompromised condition
- Patients who have had a known allergic reaction to any NSAIDS or aspirin (asthma, urticaria, allergic-type reaction)
- Patients with a prior history of cervical cancer
- Patients with hypersensitivity to Celecoxib
- Patients with a known allergic reaction to sulfonamides
- Patients with a history of peptic ulcer disease
- Patients currently using fluconazole or lithium
- Patients with a chronic or acute renal, or hepatic disorder, a significant bleeding disorder, or any other condition which in the investigator's opinion might preclude study participation for the duration of the trial
- Patients with a history of transient ischemic attack (TIA), stroke, cardiovascular disease or uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (43)
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Carle Clinic-Urbana Main
Urbana, Illinois, 61801, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Gynecologic Oncology Network
Greenville, North Carolina, 27834, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Rader JS, Sill MW, Beumer JH, Lankes HA, Benbrook DM, Garcia F, Trimble C, Tate Thigpen J, Lieberman R, Zuna RE, Leath CA 3rd, Spirtos NM, Byron J, Thaker PH, Lele S, Alberts D. A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017 May;145(2):291-297. doi: 10.1016/j.ygyno.2017.02.040. Epub 2017 Mar 10.
PMID: 28285845DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon for Michael Sill, PhD
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Janet Rader
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2004
First Posted
April 8, 2004
Study Start
June 1, 2005
Primary Completion
September 1, 2012
Last Updated
September 15, 2017
Results First Posted
September 15, 2017
Record last verified: 2017-08