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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 43
- 主要终点
- Histologic Regression
研究概览
简要总结
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.
详细描述
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 the post-treatment excisional biopsy.
II. To determine the toxicity of celecoxib (400 mg once daily) as assessed by Common Terminology Criteria for Adverse Events in this patient population of women with CIN 2/3 or CIN 3.
SECONDARY OBJECTIVES:
I. To assess whether treatment with celecoxib changes the number of quadrants containing acetowhite lesions as determined through colposcopic examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (celecoxib)
Patients receive oral celecoxib once daily for 14-18 weeks.
干预措施: Celecoxib (Drug)
Arm I (celecoxib)
Patients receive oral celecoxib once daily for 14-18 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Patients receive oral placebo once daily for 14-18 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Patients receive oral placebo once daily for 14-18 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Histologic Regression
时间窗: Post treatment evaluation was done 14 to 18 weeks after treatment randomization
Whether or not patients with CIN 2/3 or CIN 3 upon entry experience a complete remission (or partial regression to CIN 1) in the post-treatment excisional biopsy.
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Number of participants with a grade of 3 or higher during the treatment period.
次要结局
未报告次要终点