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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)

Phase 2
18 Years
Open (Enrolling)
Cervical Cancer, Precancerous Condition

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Trial Information

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)



- 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.


- 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

- 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.

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

- 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



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


- 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


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- Not specified


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Histologic complete response

Safety Issue:


Principal Investigator

Janet S. Rader, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ



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