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Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

2014-08-27 03:54:46 | BioPortfolio

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing cervical cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix.

Description

OBJECTIVES:

- Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo.

- Compare the toxicity of these drugs in these patients.

- Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-grade squamous intraepithelial lesion status (cervical intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral celecoxib twice daily for 1 month.

- Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity. All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 1-2 years.

Study Design

Primary Purpose: Treatment

Conditions

Stage 0 Cervical Cancer

Intervention

celecoxib, anti-cytokine therapy, antiangiogenesis therapy, biological therapy, cancer prevention intervention, chemoprevention of cancer, enzyme inhibitor therapy, growth factor antagonist therapy

Status

Withdrawn

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:46-0400

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