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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


Phase 2
20 Years
60 Years
Not Enrolling
Both
Non-melanomatous Skin Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

David R. Bickers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068840

NCT ID:

NCT00025051

Start Date:

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • Skin Neoplasms

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032