Overview

This trial is active, not recruiting.

Conditions cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
Treatments hydrocortisone/placebo, celecoxib
Phase phase 2
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date June 2005
End date January 2100
Trial size 130 participants
Trial identifier NCT00081263, CDR0000360805, GOG-0207, NCI-2009-00583, U10CA101165

Summary

This randomized phase II trial is studying how well celecoxib works in preventing cervical cancer in patients with CIN. 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Patients receive oral celecoxib once daily for 14-18 weeks.
celecoxib Celebrex
Given orally
(Placebo Comparator)
Patients receive oral placebo once daily for 14-18 weeks.
hydrocortisone/placebo
Given orally

Primary Outcomes

Measure
Complete or partial response determined by CIN level assignment during histological evaluation of the post-treatment excisional biopsy
time frame: Up to 18 weeks
Frequency and severity of observed adverse effects assessed by Common Terminology Criteria for Adverse Events
time frame: Up to 18 weeks

Eligibility Criteria

Female participants at least 18 years old.

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 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 - Performance status - GOG 0-2 - 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 - No prior renal transplantation - At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or aspirin - No other concurrent NSAIDs or aspirin - No concurrent fluconazole or lithium

Additional 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 3)
Principal investigator Janet Rader
Description PRIMARY OBJECTIVES: I. 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. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the effect of this drug on changes in lesion size in these patients. II. Determine the effect of this drug on human papillomavirus (HPV) viral load in these patients. III. 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.