Cervical Carcinoma Clinical Trial
Official title:
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)
Verified date | August 2017 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
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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