Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Carcinogenesis

Erythema

Skin Diseases

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Mitogens

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

celecoxib

anti-cytokine therapy

antiangiogenesis therapy

biological therapy

cancer prevention intervention

chemoprevention of cancer

growth factor antagonist therapy

David R. Bickers, MD

RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.

OBJECTIVES:

* Determine whether celecoxib decreases ultraviolet(UV)-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to one of two treatment arms.

* Arm I: Participants receive oral celecoxib twice daily for approximately 120 days.
* Arm II: Participants receive oral placebo twice daily for approximately 120 days.

Skin biopsies of UV-exposed sites are evaluated.

Participants are followed for up to 5 weeks post-treatment.

PROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study within 8 months.

Celecoxib in Preventing Skin Cancer

A Phase II, Double-Blind, Placebo-Controlled Clinical Trial To Assess Celecoxib As A Chemopreventive Agent Inhibiting UV-Induced Erythema And Cutaneous Carcinogenesis As Assessed Through Surrogate Biological Markers In Biopsied Skin After Exposure Of Skin In Normal Volunteers Ages 20-60 Years Old With Fitzpatrick Type I, II, III And IV Skin To UV-Radiation From Artificial Light Sources

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Uterine Cervical Neoplasms

Squamous Intraepithelial Lesions of the Cervix

Carcinoma in Situ

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Cervical Dysplasia

Precancerous Conditions

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

enzyme inhibitor therapy

William R. Robinson, MD

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.

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.

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

S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix

SWOG Cancer Research Network

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Celecoxib in Preventing Skin Cancer	NCT00025051	Non-melanomatou...	celecoxib anti-cytokine t... antiangiogenesi... biological ther... cancer preventi... chemoprevention... growth factor a...	20 Years - 60 Years	National Cancer Institute (NCI)
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix	NCT00072540	Stage 0 Cervica... High-grade Squa...	celecoxib anti-cytokine t... antiangiogenesi... biological ther... cancer preventi... chemoprevention... enzyme inhibito... growth factor a...	18 Years -	SWOG Cancer Research Network
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix	NCT00072540	Stage 0 Cervica... High-grade Squa...	celecoxib anti-cytokine t... antiangiogenesi... biological ther... cancer preventi... chemoprevention... enzyme inhibito... growth factor a...	18 Years -	SWOG Cancer Research Network
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix	NCT00072540	Stage 0 Cervica... High-grade Squa...	celecoxib anti-cytokine t... antiangiogenesi... biological ther... cancer preventi... chemoprevention... enzyme inhibito... growth factor a...	18 Years -	SWOG Cancer Research Network
Celecoxib in Preventing Skin Cancer	NCT00025051	Non-melanomatou...	celecoxib anti-cytokine t... antiangiogenesi... biological ther... cancer preventi... chemoprevention... growth factor a...	20 Years - 60 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for chemoprevention of cancer