NCT00025051撤回2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC ≥ 3,500/mm^3
- •Hemoglobin ≥ 12.0 g/dL
- •No bleeding disorder
- •Bilirubin ≤ 20% above upper limit of normal (ULN)
- •AST and ALT ≤ 20% above ULN
- •No chronic or acute hepatic disease
- •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
- •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
- •Not specified
- •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
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Celecoxib in Preventing Head and Neck Cancer in Patients With Oral LeukoplakiaHead and Neck CancerPrecancerous ConditionNCT00101335Fox Chase Cancer Center
撤回
不适用
Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced CancerCachexiaMelanoma (Skin)PainUnspecified Adult Solid Tumor, Protocol SpecificOvarian CancerSarcomaLymphomaNCT00093678Eastern Cooperative Oncology Group
已完成
2 期
Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By SurgeryColorectal CancerNCT00336960Vanderbilt-Ingram Cancer Center24
撤回
2 期
S0212 Celecoxib in Treating Patients With High-Grade Squamous Intraepithelial Lesions of the CervixStage 0 Cervical CancerHigh-grade Squamous Intraepithelial LesionNCT00072540SWOG Cancer Research Network
已完成
2 期
Celecoxib and Trastuzumab in Treating Women With Metastatic Breast CancerBreast CancerNCT00006381Memorial Sloan Kettering Cancer Center