Cervical CarcinomaPhase 2NCT00081263
Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
A Phase 2 study testing Celecoxib and Laboratory Biomarker Analysis in people with Cervical Carcinoma and Cervical Intraepithelial Neoplasia Grade 2/3, run by Gynecologic Oncology Group at 43 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3, Stage 0 Cervical Cancer
- What is being tested?
- Celecoxib and Laboratory Biomarker Analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 43 sitesUnited States
- Study dates
- Jun 2005to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
University of Cincinnati
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
Elkhart Clinic
Elkhart, Indiana, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Union Hospital of Cecil County
Elkton, Maryland, 21921
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Gynecologic Oncology Network
Greenville, North Carolina, 27834
Borgess Medical Center
Kalamazoo, Michigan, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Community Howard Regional Health
Kokomo, Indiana, 46904
IU Health La Porte Hospital
La Porte, Indiana, 46350
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Beebe Medical Center
Lewes, Delaware, 19958
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, 44060
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016
Lakeland Hospital
Saint Joseph, Michigan, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628
Saint Louis University Hospital
St Louis, Missouri, 63110
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
Carle Clinic-Urbana Main
Urbana, Illinois, 61801
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Being tested
- Celecoxib, Laboratory Biomarker Analysis, Placebo
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177
Given orally
Laboratory Biomarker AnalysisOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I (celecoxib) | Experimental | Patients receive oral celecoxib once daily for 14-18 weeks. Receives: Drug: Celecoxib; Other: Laboratory Biomarker Analysis |
| Arm II (placebo) | Placebo comparator | Patients receive oral placebo once daily for 14-18 weeks. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post treatment evaluation was done 14 to 18 weeks after treatment randomization
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.
Measured: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startJun 2005
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janet Rader, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081263
- Sponsor's protocol ID
- GOG-0207
- Other IDs
- NCI-2009-00583, CDR0000360805, GOG-0207, GOG-0207, GOG-0207, U10CA101165
- Status last verified
- Aug 2017
- First submitted
- 7 Apr 2004
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rader JS, Sill MW, Beumer JH, Lankes HA, Benbrook DM, Garcia F, Trimble C, Tate Thigpen J, Lieberman R, Zuna RE, Leath CA 3rd, Spirtos NM, Byron J, Thaker PH, Lele S, Alberts D. A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017 May;145(2):291-297. doi: 10.1016/j.ygyno.2017.02.040. Epub 2017 Mar 10.
PubMed 28285845
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00081263
- Acronym / sponsor ID
- GOG-0207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- Sep 2012 (actual)
- First posted
- 8 Apr 2004 (estimated)
- Results
- Posted 15 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (celecoxib) | Experimental | Drug: Celecoxib, Other: Laboratory Biomarker AnalysisPatients receive oral celecoxib once daily for 14-18 weeks. |
| Arm II (placebo) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: PlaceboPatients receive oral placebo once daily for 14-18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically proven CIN 2/3 or CIN 3 diagnosed by cervical biopsy between 2 and 8 weeks prior to enrollment
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177Given orally | Drug | Arm I (celecoxib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (celecoxib), Arm II (placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven orally | Other | Arm II (placebo) |
Primary outcome
Histologic Regression
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28285845Rader JS, Sill MW, Beumer JH, Lankes HA, Benbrook DM, Garcia F, Trimble C, Tate Thigpen J, Lieberman R, Zuna RE, Leath CA 3rd, Spirtos NM, Byron J, Thaker PH, Lele S, Alberts D. A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017 May;145(2):291-297. doi: 10.1016/j.ygyno.2017.02.040. Epub 2017 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Rader principal investigator
NRG Oncology
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib and Laboratory Biomarker Analysis in people with Cervical Carcinoma and Cervical Intraepithelial Neoplasia Grade 2/3, run by Gynecologic Oncology Group at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic Regression (time frame: Post treatment evaluation was done 14 to 18 weeks after treatment randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00081263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.