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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00081263
Other study ID # GOG-0207
Secondary ID NCI-2009-00583CD
Status Completed
Phase Phase 2
First received April 7, 2004
Last updated September 13, 2017
Start date June 2005

Study information

Verified date August 2017
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 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.

II. To determine the efficacy of celecoxib treatment in changing human papillomavirus (HPV) viral load in cervical cells.

III. To examine the association of histologic response; HPV viral load; lesion size; proliferation index (marker of proliferation Ki-67 [Ki67]), apoptosis index (terminal deoxynucleotidyl transferase (TdT)-mediated dUTP nick end labelin [TUNEL] assay), angiogenesis (vascular endothelial growth factor [VEGF]), and cyclooxygenase-2 (COX-2) in tissue; the amount of VEGF and basic fibroblast growth factor (bFGF) in serum before and after treatment; and the amount of celecoxib present in serum during treatment. Cervical cytology karyometry will be assessed as a potential marker for regression IV. To determine the feasibility of digital imaging, web-based review of histopathology in a Gynecologic Oncology Group (GOG) study.

V. To compare the diagnoses of the web-based review of histopathology with the diagnoses of GOG's standard procedure.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral celecoxib once daily for 14-18 weeks.

ARM II: Patients receive oral placebo once daily for 14-18 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Celecoxib
Given orally
Other:
Laboratory Biomarker Analysis
Correlative studies
Placebo
Given orally

Locations

Country Name City State
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States University of Cincinnati Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Gynecologic Oncology Network Greenville North Carolina
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Community Howard Regional Health Kokomo Indiana
United States IU Health La Porte Hospital La Porte Indiana
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Beebe Medical Center Lewes Delaware
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Lake University Ireland Cancer Center Mentor Ohio
United States Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Rutgers New Jersey Medical School Newark New Jersey
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst North Carolina
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Carilion Clinic Gynecological Oncology Roanoke Virginia
United States Lakeland Hospital Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Louis University Hospital Saint Louis Missouri
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
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 Montefiore Medical Center - Moses Campus The Bronx New York
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Carle Clinic-Urbana Main Urbana Illinois
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other To Examine the Association of Histologic Response in COX-2 in Tissue Up to 18 weeks
Other To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment Up to 18 weeks
Other HPV Viral Load Before and After Treatment Up to 18 weeks
Other To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment. Up to 18 weeks
Other Levels of Serum bFGF Up to 18 weeks
Other Levels of Serum VEGF Up to 18 weeks
Other To Determine the Feasibility of Digital Imaging Using Pathologist's Diagnosis and Diagnostic Technique (Web-based or Standard Method). Baseline
Other To Examine the Association of Histologic Response in Proliferation Index (Ki67). Up to 18 weeks
Other Proportion of Patients Whose Eligibility Can be Successfully Determined Using the Web-based Review Baseline
Other The Number of Quadrants Involving CIN Up to 18 weeks
Other To Examine the Association of Histologic Response in Apoptosis Index (TUNEL Assay) Up to 18 weeks
Other To Examine the Association of Histologic Response in Angiogenisis (VEGF) Up to 18 weeks
Primary Histologic Regression 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. Post treatment evaluation was done 14 to 18 weeks after treatment randomization
Primary Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Number of participants with a grade of 3 or higher during the treatment period. Assessed every cycle while on treatment, 30 days after the last cycle of treatment
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