Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

Completed · Phase 2 · Has a placebo group

Conditions studied: Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3, Stage 0 Cervical Cancer

In brief

This randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

Key facts

Study ID

NCT00081263

Run by

Gynecologic Oncology Group

People needed

130

Starts

2005-06-01

Last updated by the study team

2017-09-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically proven CIN 2/3 or CIN 3 diagnosed by cervical biopsy between 2 and 8 weeks prior to enrollment
• For a patient to be eligible, the pathology report must clearly state "CIN 2/3" or "CIN 3" or must state "moderate-severe dysplasia", "moderate-severe dyskaryosis," "severe dysplasia," or "severe dyskaryosis;" patients with a diagnosis of CIN 2 alone or moderate dysplasia or dyskaryosis alone are not eligible for this study (3/26/2007)
• Patients must have a satisfactory (readable, good quality) colposcopic evaluation at least 14 days after diagnostic biopsy
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients must have colposcopically visible cervical lesion at entry consistent with biopsy
• Patients must have a negative urine pregnancy test; women of childbearing potential must practice an acceptable form of contraception (e.g. intrauterine device, contraceptive pills, diaphragm, condoms)
• Patients must have a GOG Performance Status of 0, 1, or 2
• Patients must agree to refrain from using non-steroidal anti-inflammatory drugs (NSAIDS) and aspirin during the time they are taking the study medication
• Patients must be good candidates for delayed treatment of their CIN, i.e. they must be reliable to return for follow-up and provide a combination of at least three phone numbers or addresses for contact
• Hemoglobin (HgB) greater than 11.0g/dl
• White blood cell (WBC) count greater than 3000/mcl
• Platelet count greater than 125,000/mcl (3/26/2007)
• Creatinine less than or equal to 1.5 x upper limit normal (ULN)
• Total bilirubin less than or equal to 1.5 x ULN excluding Gilbert's disease
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.0 x ULN

You may not qualify if…

• Patients who are pregnant or lactating
• Patients with cytologic or biopsy evidence of endocervical dysplasia or invasive cancer
• Patients with undiagnosed abnormal vaginal bleeding
• Patients who have previously taken celecoxib or any other COX-2 inhibitor at a frequency of greater than 3 times per week within 2 months (60 days) prior to randomization; patients can use Naproxen without restriction (6/23/2008)
• Patients with a known immunocompromised condition
• Patients who have had a known allergic reaction to any NSAIDS or aspirin (asthma, urticaria, allergic-type reaction)
• Patients with a prior history of cervical cancer
• Patients with hypersensitivity to Celecoxib
• Patients with a known allergic reaction to sulfonamides
• Patients with a history of peptic ulcer disease
• Patients currently using fluconazole or lithium
• Patients with a chronic or acute renal, or hepatic disorder, a significant bleeding disorder, or any other condition which in the investigator's opinion might preclude study participation for the duration of the trial
• Patients with a history of transient ischemic attack (TIA), stroke, cardiovascular disease or uncontrolled hypertension

Where it is running

• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Carle Clinic-Urbana Main — Urbana, Illinois, United States
• Elkhart Clinic — Elkhart, Indiana, United States
• Michiana Hematology Oncology PC-Elkhart — Elkhart, Indiana, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Community Howard Regional Health — Kokomo, Indiana, United States
• IU Health La Porte Hospital — La Porte, Indiana, United States
• Michiana Hematology Oncology PC-Mishawaka — Mishawaka, Indiana, United States
• Saint Joseph Regional Medical Center-Mishawaka — Mishawaka, Indiana, United States
• Michiana Hematology Oncology PC-Plymouth — Plymouth, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Michiana Hematology Oncology PC-South Bend — South Bend, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Michiana Hematology Oncology PC-Westville — Westville, Indiana, United States
• Union Hospital of Cecil County — Elkton, Maryland, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Lakeland Hospital — Saint Joseph, Michigan, United States
• Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
• University of Missouri - Ellis Fischel — Columbia, Missouri, United States
• Saint Louis University Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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