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Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia

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ClinicalTrials.gov Identifier: NCT00081263
Recruitment Status : Completed
First Posted : April 8, 2004
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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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. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

Condition or disease Intervention/treatment Phase
Cervical Carcinoma Cervical Intraepithelial Neoplasia Grade 2/3 Stage 0 Cervical Cancer Drug: Celecoxib Other: Laboratory Biomarker Analysis Other: Placebo Phase 2

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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)
Study Start Date : June 2005
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (celecoxib)
Patients receive oral celecoxib once daily for 14-18 weeks.
 Drug: Celecoxib
Given orally
Other Names:
  • Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-
  • Celebrex
  • SC-58635
  • YM 177

Other: Laboratory Biomarker Analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive oral placebo once daily for 14-18 weeks.
 Other: Laboratory Biomarker Analysis
Correlative studies

Other: Placebo
Given orally
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. To Examine the Association of Histologic Response in COX-2 in Tissue [ Time Frame: Up to 18 weeks ]
  2. To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment [ Time Frame: Up to 18 weeks ]
  3. HPV Viral Load Before and After Treatment [ Time Frame: Up to 18 weeks ]
  4. To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment. [ Time Frame: Up to 18 weeks ]
  5. Levels of Serum bFGF [ Time Frame: Up to 18 weeks ]
  6. Levels of Serum VEGF [ Time Frame: Up to 18 weeks ]
  7. To Determine the Feasibility of Digital Imaging Using Pathologist's Diagnosis and Diagnostic Technique (Web-based or Standard Method). [ Time Frame: Baseline ]
  8. To Examine the Association of Histologic Response in Proliferation Index (Ki67). [ Time Frame: Up to 18 weeks ]
  9. Proportion of Patients Whose Eligibility Can be Successfully Determined Using the Web-based Review [ Time Frame: Baseline ]
  10. The Number of Quadrants Involving CIN [ Time Frame: Up to 18 weeks ]
  11. To Examine the Association of Histologic Response in Apoptosis Index (TUNEL Assay) [ Time Frame: Up to 18 weeks ]
  12. To Examine the Association of Histologic Response in Angiogenisis (VEGF) [ Time Frame: Up to 18 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081263


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Janet Rader NRG Oncology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00081263    
Other Study ID Numbers: GOG-0207
NCI-2009-00583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000360805
GOG-0207 ( Other Identifier: NRG Oncology )
GOG-0207 ( Other Identifier: DCP )
GOG-0207 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2004    Key Record Dates
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Celecoxib
Benzenesulfonamide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Carbonic Anhydrase Inhibitors