Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00081263

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia (CIN).

PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing cervical cancer in patients with CIN.

Condition	Intervention	Phase
Cervical Cancer Precancerous/Nonmalignant Condition	Drug: celecoxib Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
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 CIN 3)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Histologic complete response [ Designated as safety issue: No ]
Frequency and severity of adverse effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HPV viral load, proliferation index, apoptosis index by TUNEL assay, angiogenesis (VEGF), and COX-2 in tissue, levels of VEGF and bFGF pre- and post-treatment in serum, and levels of celecoxib in serum following treatment [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2005

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral celecoxib once daily for 14-18 weeks.	Drug: celecoxib Given orally
Arm II: Placebo Comparator Patients receive oral placebo once daily for 14-18 weeks.	Other: placebo Given orally

Detailed Description:

OBJECTIVES:

Primary

Determine the efficacy of celecoxib, in terms of achieving histologic complete or partial response, in patients with cervical intraepithelial neoplasia (CIN) 2/3 or 3.
Determine the toxicity of this drug in these patients.

Secondary

Determine the effect of this drug on changes in lesion size in these patients.
Determine the effect of this drug on human papillomavirus (HPV) viral load in these patients.
Correlate histologic response, HPV viral load, lesion size, proliferation index, apoptosis index, angiogenesis (VEGF) and COX-2 in tissue, amount of VEGF and bFGF in serum, and serum celecoxib levels during treatment in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to lesion size (covering ≤ ½ area of the cervix vs covering > ½ area of the cervix) and degree of cervical intraepithelial neoplasia (CIN) (CIN 2/3 vs CIN 3). 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. Patients undergo colposcopy at week 8 and between weeks 14 and 18. Between weeks 14 and 18, patients with evidence of disease also undergo large loop excision of the transformation zone (cone biopsy) or cervical biopsy and patients with no evidence of disease undergo a cervical biopsy to confirm the absence of disease on colposcopy.

PROJECTED ACCRUAL: A maximum of 100 patients (50 per treatment arm) will be accrued for this study within 13 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3 by cervical biopsy 2-8 weeks prior to study entry
- Pathology report must clearly state "CIN 2/3" or "3" OR "moderate-severe dysplasia," "moderate-severe dyskaryosis," "severe dysplasia," or "sever dyskaryosis."
  - No CIN 2 alone OR moderate dysplasia or dyskaryosis alone
Colposcopically visible cervical lesion at study entry that is consistent with biopsy
No evidence of endocervical dysplasia or invasive cancer by cytology or biopsy
No history of cervical cancer

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

GOG 0-2

Life expectancy

Not specified

Hematopoietic

Platelet count > 125,000/mm^3
Hemoglobin > 11.0 g/dL
WBC > 3,000/mm^3
No significant bleeding disorder

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN) (> 1.5 times ULN allowed if due to Gilbert's disease)
AST and ALT < 2.0 times ULN
No hepatic disorder

Renal

Creatinine ≤ 1.5 times ULN
No known renal failure

Cardiovascular

No history of transient ischemic attack or stroke
No history of cardiovascular disease
No uncontrolled hypertension

Other

No undiagnosed abnormal vaginal bleeding
No known immunocompromised condition
No known allergic reaction (such as asthma, urticaria, or other reaction) to NSAIDs or aspirin
No known hypersensitivity to celecoxib
No known allergic reaction to sulfonamides
No history of peptic ulcer disease
Must be good candidate for delayed treatment of CIN (i.e., deemed reliable to return for follow-up and provide adequate contact information)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

No prior renal transplantation

Other

At least 15 days since prior nonsteriodal anti-inflammatory agents (NSAIDs) or aspirin
No other concurrent NSAIDs or aspirin
No concurrent fluconazole or lithium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081263

Hide Study Locations

Locations

United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40292
United States, Maryland
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nevada
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States, 89102
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, North Carolina
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Gynecologic Oncology Network
Greenville, North Carolina, United States, 27834
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States, 74136-1929
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
United States, Virginia
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States, 24014

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Janet S. Rader, MD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gynecologic Oncology Group ( Philip J. DiSaia )
Study ID Numbers:	CDR0000360805, GOG-0207
Study First Received:	April 7, 2004
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00081263 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Celecoxib
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Cervical Intraepithelial Neoplasia
Carcinoma

Neoplasms
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Carcinoma in Situ
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009