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Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia Clinical research trials and Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia. Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia  Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
For Condition: Cervical Cancer,high-grade squamous intraepithelial lesion
Status: Not yet recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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. PURPOSE: Randomizedphase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.
Details: OBJECTIVES: Primary - Determine the efficacy of celecoxib, in terms of achieving histologic complete or partial response, in patients with cervical intraepithelial neoplasia 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 randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral celecoxib twice daily. - Arm II: Patients receive oral placebo twice daily. Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Patients undergo colposcopy at week 8 and between weeks 14 and 18. Between weeks 14 and 18, patients also undergo large loop excision of the transformation zone or cone biopsy. PROJECTED ACCRUAL: A maximum of 100 patients (50 per treatment arm) will be accrued for this study within 13 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 17 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cervical intraepithelial neoplasia 3 (CIN 3) by cervical biopsy 2-8 weeks prior to study entry - 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 - 17 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - No known renal failure 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolynMuller, , Simmons Cancer Center
Additional Information:
Study ID Numbers: CDR0000360805; GOG-0207
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081263
Other Cervical Cancer 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 Cervical Cancer Clinical Trials
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Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
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