Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia



Status:Archived
Conditions:Cervical Cancer, Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011

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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)


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.


OBJECTIVES:

Primary

- 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.

- Determine the toxicity of this drug in these patients.

Secondary

- Determine the effect of this drug on changes in lesion size in these patients.

- Determine the effect of this drug on human papillomavirus (HPV) viral load in these
patients.

- 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.

PROJECTED ACCRUAL: A maximum of 130 patients (39 per treatment arm) will be accrued for this
study within 13 months.


We found this trial at
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Roanoke, VA
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106 Bow Street
Elkton MD, Maryland 21921
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Elkton MD, MD
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902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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Lewes, DE
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800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
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Oklahoma City, OK
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Ft Sam Houston, Texas 78234
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Ft Sam Houston, TX
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4018 W Capitol Ave.
Little Rock, Arkansas 72205
(501) 296-1200
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences The Winthrop P. Rockefeller...
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Little Rock, AR
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Newark, Delaware 19713
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Newark, DE
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Pinehurst, North Carolina 28374
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Pinehurst, NC
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Sioux Falls, South Dakota 57117
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Sioux Falls, SD
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St Louis, Missouri 63110
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St Louis, MO
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660 S Euclid Ave
St. Louis, Missouri 63110
(800) 600-3606
Siteman Cancer Center The Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University...
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St. Louis, MO
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Tucson, AZ
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