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Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

Information source: Gynecologic Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Cancer; Cervical Intraepithelial Neoplasia Grade 2; Cervical Intraepithelial Neoplasia Grade 3

Intervention: hydrocortisone/placebo (Other); celecoxib (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Gynecologic Oncology Group

Official(s) and/or principal investigator(s):
Janet Rader, Principal Investigator, Affiliation: Gynecologic Oncology Group


This randomized phase II trial is studying how well celecoxib works in preventing cervical cancer in patients with CIN. 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).

Clinical Details


Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome:

Complete or partial response determined by CIN level assignment during histological evaluation of the post-treatment excisional biopsy

Frequency and severity of observed adverse effects assessed by Common Terminology Criteria for Adverse Events

Detailed description: PRIMARY OBJECTIVES: I. Determine the efficacy of celecoxib, in terms of achieving histologic complete or partial response, in patients with cervical intraepithelial neoplasia (CIN) 2/3 or 3. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the effect of this drug on changes in lesion size in these patients. II. Determine the effect of this drug on human papillomavirus (HPV) viral load in these patients. III. Correlate histologic response, HPV viral load, lesion size, proliferation index, apoptosis index, angiogenesis (VEGF) and COX-2 in tissue, amount of VEGF and bFGF in serum, and serum celecoxib levels during treatment in these patients. 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. ARM I: Patients receive oral celecoxib once daily for 14-18 weeks. ARM II: Patients receive oral placebo once daily for 14-18 weeks. Patients undergo colposcopy at week 8 and between weeks 14 and 18. Between weeks 14 and 18, patients with evidence of disease also undergo large loop excision of the transformation zone (cone biopsy) or cervical biopsy and patients with no evidence of disease undergo a cervical biopsy to confirm the absence of disease on colposcopy.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- 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."

- No CIN 2 alone OR moderate dysplasia or dyskaryosis alone

- Colposcopically visible cervical lesion at study entry that is consistent with biopsy

- No evidence of endocervical dysplasia or invasive cancer by cytology or biopsy

- No history of cervical cancer

- Performance status - GOG 0-2

- Platelet count > 125,000/mm^3

- Hemoglobin > 11. 0 g/dL

- WBC > 3,000/mm^3

- No significant bleeding disorder

- Bilirubin ≤ 1. 5 times upper limit of normal (ULN) (> 1. 5 times ULN allowed if due to

Gilbert's disease)

- AST and ALT < 2. 0 times ULN

- No hepatic disorder

- Creatinine ≤ 1. 5 times ULN

- No known renal failure

- No history of transient ischemic attack or stroke

- No history of cardiovascular disease

- No uncontrolled hypertension

- No undiagnosed abnormal vaginal bleeding

- No known immunocompromised condition

- No known allergic reaction (such as asthma, urticaria, or other reaction) to NSAIDs

or aspirin

- No known hypersensitivity to celecoxib

- No known allergic reaction to sulfonamides

- No history of peptic ulcer disease

- Must be good candidate for delayed treatment of CIN (i. e., deemed reliable to return

for follow-up and provide adequate contact information)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior renal transplantation

- At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or


- No other concurrent NSAIDs or aspirin

- No concurrent fluconazole or lithium

Locations and Contacts

Arizona Cancer Center at University Medical Center North, 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

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana 46514, 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 46545-1470, United States

Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana 46545-1470, 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

The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky 40202, United States

Union Hospital of Cecil County, Elkton MD, 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

Marie Yeager Cancer Center, Saint Joseph, Michigan 49085, United States

Lakeland Hospital, St. Joseph, Michigan 49085, United States

University of Missouri - Ellis Fischel, Columbia, Missouri 65212, United States

Saint Louis University Hospital, Saint Louis, Missouri 63110, United States

Washington University School of Medicine, Saint Louis, Missouri 63110, United States

Women's Cancer Center of Nevada, Las Vegas, Nevada 89169, United States

UMDNJ - New Jersey Medical School, Newark, New Jersey 07103, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico 87106, United States

Montefiore Medical Center - Moses Campus, Bronx, New York 10467-2490, United States

University of North Carolina, 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

Tulsa Cancer Institute, Tulsa, Oklahoma 74146, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota 57117-5134, United States

Vanderbilt-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

Additional Information

Starting date: June 2005
Last updated: August 8, 2014

Page last updated: August 20, 2015

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