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Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix Clinical research trials and Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix. Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix clinical trial. Human subjects frequently get the finest healthcare available for their Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
For Condition: high-grade squamous intraepithelial lesion,stage 0 cervical cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing cervical cancer. PURPOSE: Randomizedphase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-gradesquamous intraepithelial lesions of the cervix.
Details: OBJECTIVES: - Compare the complete response rate in patients with high-grade squamous intraepithelial lesions of the cervix treated with celecoxib vs placebo. - Compare the toxicity of these drugs in these patients. - Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and human papilloma virus expression in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-grade squamous intraepithelial lesion status (cervical intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral celecoxib twice daily for 1 month. - Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity. All patients then undergo loop electrosurgical excision procedure or cone biopsy to determine response. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed high-grade squamous intraepithelial lesions (HGSIL) of the cervix - Cervical intraepithelial neoplasia (CIN) 2 (moderate dysplasia) OR CIN 3 (severe dysplasia, carcinoma in situ) - Must have remaining HGSIL after biopsy - No suspicion of invasive cancer by colposcopy within the past 28 days - No invasive or preinvasive high-grade intraepithelial neoplasia by endocervical curettage within the past 56 days PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - SGOT and SGPT less than 2.0 times upper limit of normal (ULN) - Bilirubin less than 2.0 times ULN Renal - Creatinine less than 2.0 mg/dL Immunologic - No prior asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs - No allergy to sulfonamides - No known sensitivity to celecoxib - No known AIDS or HIV-associated complex Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior pelvic radiotherapy Surgery - See Disease Characteristics Other - More than 3 months since prior topical medications for genital condyloma - No prior treatment for squamous intraepithelial lesions - No concurrent topical medications for genital condyloma - No other concurrent treatment - No concurrent chronic (daily for more than 30 days) aspirin - No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesColtman, Study Chair, San Antonio Cancer Institute
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Seth Lerner 713-798-5906
Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Bart Barlogie 501-526-2873
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting David Fishman 312-926-7365
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Abdul-Rahman Jazieh 513-584-3830
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
Tripler Army Medical Center *Recruiting*
Honolulu, Hawaii, 96859-5000
United States
Recruiting Brian Issell 808-433-4089
Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington, Kentucky, 40502-2236
United States
Recruiting Michael Doukas 859-281-4956
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0912
United States
Recruiting Laurence Baker 734-936-3983
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting David Schuller 614-293-4878
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Daniel Petrylak 212-305-1731
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Geoffrey Weiss 210-617-5120
Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Steven Grunberg 802-847-8400
Veterans Affairs Medical Center - Boston (Jamaica Plain) *Recruiting*
Jamaica Plain, Massachusetts, 02130
United States
Recruiting Michelle Hankins 617-232-9500
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Anthony Elias 720-848-1622
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting Peter Carroll 415-221-4810
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa, California, 95403
United States
Recruiting Ian Anderson 707-521-3859
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-8000
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0565
United States
Recruiting Robert Whitehead 409-772-1164
Veterans Affairs Medical Center - Portland *Recruiting*
Portland, Oregon, 97207
United States
Recruiting Craig Nichols 503-220-8262
Veterans Affairs Medical Center - Denver *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Madeleine Kane 303-399-8020 ext. 3129
Western New York Urology Associates *Recruiting*
Buffalo, New York, 14220
United States
Recruiting Scott Perrapato 716-828-3369
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-587-7566
CCOP - Beaumont *Recruiting*
Royal Oak, Michigan, 48073-6769
United States
Recruiting David Decker 248-551-7695
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
David Grant Medical Center *Recruiting*
Travis Air Force Base, California, 94535
United States
Recruiting David Gandara 707-423-7300
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City, Utah, 84148
United States
Recruiting Wolfram Samlowski 801-582-1565
Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez, California, 94553
United States
Recruiting David Gandara 925-372-2064
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston, South Carolina, 29401-5799
United States
Recruiting Carolyn Reed 843-789-7865
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson, Arizona, 85723
United States
Recruiting Thomas Miller 520-792-1450 ext. 16631
Cancer Research Center of Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting William Robinson 806-355-9703
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Saul Rivkin 206-386-2929
Eastern Virginia Medical School *Recruiting*
Norfolk, Virginia, 23510-1115
United States
Recruiting Paul Schellhammer 804-628-2409
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112-5550
United States
Recruiting Wolfram Samlowski 801-585-0255
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Scott Lippman 713-745-3672
Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting Laurence Baker 734-769-7100
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-1850
Veterans Affairs Medical Center - Temple *Recruiting*
Temple, Texas, 76504
United States
Recruiting Phalguni Mukhopadhyay 254-778-4811 ext. 4809
Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-589-5250
Brooke Army Medical Center *Recruiting*
Fort Sam Houston, Texas, 78234-6200
United States
Recruiting Mitchell Garrison 210-916-0504
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Randall Holcombe 714-456-5153
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting James Thigpen 601-362-4471
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City, Missouri, 64128
United States
Recruiting Sarah Taylor 816-861-4700 ext. 491
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Nirmala Bhoopalam 708-202-2782
CCOP - Montana Cancer Consortium *Recruiting*
Billings, Montana, 59101
United States
Recruiting Patrick Cobb 406-259-2245
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Richard Fisher 585-275-0842
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati, Ohio, 45220-2288
United States
Recruiting Abdul-Rahman Jazieh 513-861-3100 ext. 6537
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431-5000
United States
Recruiting Patrick Williams 253-968-2505
Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87108-5138
United States
Recruiting Douglas Clark 505-243-4039
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7353
United States
Recruiting Sarah Taylor 913-588-6029
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paul Petruska 314-577-8854
Veterans Affairs Medical Center - Memphis *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Mohammad Jahanzeb 901-523-8990
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit, Michigan, 48201-1932
United States
Recruiting Lawrence Flaherty 313-576-1000
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix, Arizona, 85012
United States
Recruiting Thomas Kummet 602-277-5551
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-6346
Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield, Michigan, 48075
United States
Recruiting Anibal Drelichman 313-552-0620
Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton, Ohio, 45428-1002
United States
Recruiting Howard Gross 937-268-6511
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cheryl Willman 505-272-5837
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Geoffrey Weiss 210-617-5120
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-270-0501
Veterans Affairs Medical Center - Albany *Recruiting*
Albany, New York, 12208
United States
Recruiting James Holland 518-462-3311 ext. 2328
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting John Barstis 310-825-5268
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Michael Doukas 859-257-4500
Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting William Schubach 206-764-2265
CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting Patrick Henry 314-569-6573
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Southwest Cancer Center at UMC *Recruiting*
Lubbock, Texas, 79415-3364
United States
Recruiting Werner W. DeRiese 806-775-8590
Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Glenn Mills 318-221-8411
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Joseph Szumowski 510-465-8570
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Thomas Miller 520-626-2667
Veterans Affairs Medical Center - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Gauri Varadhachary 713-791-1414 ext. 5340
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
Additional Information:
Study ID Numbers: CDR0000340176; SWOG-S0212
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072540
Other High-Grade Squamous Intraepithelial Lesion Studies:
1. Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
2. Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Related Studies:
Other high-grade squamous intraepithelial lesion Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
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