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Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

2014-08-27 03:54:26 | BioPortfolio

Summary

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.

Description

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.

Study Design

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

Conditions

Cervical Cancer

Intervention

celecoxib, placebo

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock
Arkansas
United States
72205

Status

Suspended

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:26-0400

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Medical and Biotech [MESH] Definitions

Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

Tumors or cancer of the UTERINE CERVIX.

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