Status:
COMPLETED
Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Carcinoma
Cervical Intraepithelial Neoplasia Grade 2/3
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the efficacy of celecoxib to induce complete remission (or partial regression to cervical intraepithelial neoplasia (CIN) 1) of CIN 2/3 or CIN 3 as evaluated in th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00081263
Start Date
June 1 2005
Last Update
September 15 2017
Active Locations (43)
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1
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Beebe Medical Center
Lewes, Delaware, United States, 19958
4
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718