- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00025051
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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
- Fitzpatrick type I-IV skin
- No history of photosensitivity (e.g., systemic or discoid lupus erythematosus, polymorphous light eruption, or photocontact dermatitis)
- No history of abnormal tanning responses or other unusual reactions to natural or artificial light sources
- Willing to wear sun-protective clothing and SPF 15-49 sunscreen
- Willing and able to restrict the frequency of high ultraviolet-exposure activities (e.g., exposure to sunlight, tanning boxes, or other artificial light sources)
- No history of keloid formation
PATIENT CHARACTERISTICS:
Age:
- 20 to 60
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC ≥ 3,500/mm^3
- Hemoglobin ≥ 12.0 g/dL
- No bleeding disorder
Hepatic:
- Bilirubin ≤ 20% above upper limit of normal (ULN)
- AST and ALT ≤ 20% above ULN
- No chronic or acute hepatic disease
Renal:
- Creatinine ≤ 20% above ULN
- No chronic or acute renal disease
Gastrointestinal:
- No active gastrointestinal disease (e.g., inflammatory bowel disease)
- No pancreatic disease
- No esophageal, gastric, pyloric channel, or duodenal ulceration
Other:
- No invasive cancer except nonmelanoma skin cancer cured by excision or stage I cervical cancer
- No hypersensitivity or adverse reactions to NSAIDs, salicylates, cyclo-oxygenase-2 (COX-2) inhibitors, or sulfonamides
- No condition that would preclude the use of NSAIDs
- No clinically significant laboratory abnormalities
- No medical or psychosocial condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile participants must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent chemo-immunotherapy
Chemotherapy:
- See Biologic therapy
- At least 1 year since prior chemotherapy, including topical fluorouracil
Endocrine therapy:
- At least 2 weeks since prior topical glucocorticoids
- At least 30 days since prior systemic corticosteroids
- No concurrent systemic glucocorticoids (inhaled corticosteroids allowed)
- No concurrent topical corticosteroids
- No concurrent hormonal therapy
- Hormone replacement (e.g., estrogen or thyroid replacement) allowed
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- At least 14 days since prior aspirin (> 100 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) taken at least 3 times per week
- At least 2 weeks since prior topical alpha hydroxy acids (e.g., glycolic acid or lactic acid)
- At least 6 months since prior oral retinoids (3 months for topical retinoids to the face)
- At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulceration
- At least 30 days since prior investigational medication
- No other concurrent investigational medication
- No concurrent topical vitamin A derivatives and/or alpha hydroxy acids
- No concurrent immunosuppressive drugs
- No concurrent topical medication to the skin, including prescription and over-the-counter preparations (moisturizers and emollients allowed)
- No concurrent lithium, fluconazole, or warfarin
- No concurrent chronic NSAIDs (> 3 times per week for > 2 consecutive weeks per year)
- Concurrent cardioprotective doses of aspirin (≤ 100 mg/day) allowed
- Concurrent acetaminophen allowed
- No concurrent green tea consumption of > 2 cups per day
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Mascaramento: Dobro
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: David R. Bickers, MD, Herbert Irving Comprehensive Cancer Center
Datas de registro do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Neoplasias Cutâneas
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Inibidores da Ciclooxigenase
- Moduladores de Mitose
- Inibidores da Ciclooxigenase 2
- Celecoxibe
- Mitógenos
Outros números de identificação do estudo
- CDR0000068840
- CPMC-U19-CA81888-01-UV
- CPMC-IRB-9923
- NCI-P01-0191
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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