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Last Modified: 12/14/2008     First Published: 3/24/2004  
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Phase II Randomized Study of Celecoxib in Patients With Cervical Intraepithelial Neoplasia (CIN) 2/3 or 3

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase II
Prevention, Treatment
Active
18 and over
NCI
GOG-0207
NCT00081263

Objectives

Primary

  1. 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.
  2. Determine the toxicity of this drug in these patients.

Secondary

  1. Determine the effect of this drug on changes in lesion size in these patients.
  2. Determine the effect of this drug on human papillomavirus (HPV) viral load in these patients.
  3. 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.

Entry Criteria

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."
      • 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


Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • No prior renal transplantation

Other

  • At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or aspirin
  • No other concurrent NSAIDs or aspirin
  • No concurrent fluconazole or lithium

Patient Characteristics:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count > 125,000/mm3
  • Hemoglobin > 11.0 g/dL
  • WBC > 3,000/mm3
  • No significant bleeding disorder

Hepatic

  • 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

Renal

  • Creatinine ≤ 1.5 times ULN
  • No known renal failure

Cardiovascular

  • No history of transient ischemic attack or stroke
  • No history of cardiovascular disease
  • No uncontrolled hypertension

Other

  • 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

Expected Enrollment

100

A maximum of 100 patients (50 per treatment arm) will be accrued for this study within 13 months.

Outcomes

Primary Outcome(s)

Histologic complete response
Frequency and severity of adverse effects

Secondary Outcome(s)

HPV viral load, proliferation index, apoptosis index by TUNEL assay, angiogenesis (VEGF), and COX-2 in tissue, levels of VEGF and bFGF pre- and post-treatment in serum, and levels of celecoxib in serum following treatment

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Janet Rader, MD, Protocol chair
Ph: 314-362-3181; 800-600-3606

Trial Sites

U.S.A.
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
Delaware
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
Florida
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service
Ph: 866-574-5124
 Email: Sylvester@emergingmed.com
Illinois
  Evanston
 Evanston Northwestern Healthcare - Evanston Hospital
 Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital
Ph: 847-570-1381
  Urbana
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Kentucky
  Louisville
 James Graham Brown Cancer Center at University of Louisville
 Edward Helm, MD, FACS, MHA
Ph: 504-568-4765
Missouri
  Saint Louis
 Saint Louis University Cancer Center
 Clinical Trials Office - Saint Louis University Cancer Center
Ph: 314-977-4440
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Mutch, MD
Ph: 314-362-3181
Nevada
  Las Vegas
 Women's Cancer Center - Lake Mead
 Nick Spirtos, MD
Ph: 408-866-3843
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Clinical Trials Office - Lineberger Comprehensive Cancer Center
Ph: 877-668-0683; 919-966-4432
  Greenville
 Gynecologic Oncology Network
 Howard Homesley, MD
Ph: 252-756-5388
  Pinehurst
 FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
 Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Ph: 910-715-2200
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 William Richards
Ph: 806-796-1317
  Cleveland
 Case Comprehensive Cancer Center
 Clinical Trials Office - Case Comprehensive Cancer Center
Ph: 800-641-2422
  Mentor
 Lake/University Ireland Cancer Center
 Steven Waggoner, MD
Ph: 216-844-5011
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert Mannel, MD
Ph: 405-271-8787
  Tulsa
 Cancer Care Associates - Saint Francis Campus
 Robert Mannel, MD
Ph: 405-271-8787
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Texas
  Fort Sam Houston
 Brooke Army Medical Center
 Clinical Trials Office - Brooke Army Medical Center
Ph: 210-916-4837
Virginia
  Roanoke
 Carilion Gynecologic Oncology Associates
 Dennis Scribner, MD
Ph: 540-345-8574

Registry Information
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)
Trial Start Date 2005-06-15
Registered in ClinicalTrials.gov NCT00081263
Date Submitted to PDQ 2004-03-02
Information Last Verified 2008-12-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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