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	Temporarily closed	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

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

Outcomes

Histologic complete response
Frequency and severity of adverse effects

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

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		2009-06-23

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