Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Benzenesulfonamide; Celecoxib; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

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