S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

NCT00072540 | Withdrawn Phase 2 DMC

• 3 other identifiers: CDR0000340176S0212U10CA037429
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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: Randomized phase II trial to study the effectiveness of celecoxib in preventing cervical cancer in patients who have high-grade squamous intraepithelial lesions of the cervix.

Conditions

Stage 0 Cervical Cancer; High-grade Squamous Intraepithelial Lesion

Interventions

celecoxib DRUG

anti-cytokine therapy PROCEDURE

antiangiogenesis therapy PROCEDURE

biological therapy PROCEDURE

cancer prevention intervention PROCEDURE

chemoprevention of cancer PROCEDURE

enzyme inhibitor therapy PROCEDURE

growth factor antagonist therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions

Interventions

Celecoxib; Biological Therapy; Chemoprevention

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Therapy

Study Officials

• William R. Robinson, MD

  Harrington Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 5, 2003
• Last Updated: November 8, 2013

Record last verified: 2013-11