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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00072540 |
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.
Condition | Intervention | Phase |
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Stage 0 Cervical Cancer High-Grade Squamous Intraepithelial Lesion |
Drug: celecoxib Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological therapy Procedure: cancer prevention intervention Procedure: chemoprevention of cancer Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 1-2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Charles A. Coltman, MD | San Antonio Cancer Institute |
Investigator: | David S. Alberts, MD | University of Arizona |
Investigator: | William R. Robinson, MD | Harrington Cancer Center |
Study ID Numbers: | CDR0000340176, SWOG-S0212 |
Study First Received: | November 4, 2003 |
Last Updated: | June 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00072540 |
Health Authority: | United States: Federal Government |
Genital Diseases, Female Uterine Cervical Diseases Celecoxib Precancerous Conditions Cervical intraepithelial neoplasia Carcinoma in Situ |
Uterine Diseases Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |