Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Condition: Cervical Carcinoma; Cervical Intraepithelial Neoplasia Grade 2/3; Stage 0 Cervical Cancer
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Intervention: Celecoxib; Laboratory Biomarker Analysis; Placebo
Intervention description: Given orally; Correlative studies; Given orally
Intervention MeSH terms: Celecoxib; Benzenesulfonamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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