Celecoxib in Preventing Skin Cancer

NCT00025051 | Withdrawn Phase 2

• 4 other identifiers: CDR0000068840CPMC-U19-CA81888-01-UVCPMC-IRB-9923NCI-P01-0191
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin; squamous cell carcinoma of the skin

Interventions

celecoxib DRUG

anti-cytokine therapy PROCEDURE

antiangiogenesis therapy PROCEDURE

biological therapy PROCEDURE

cancer prevention intervention PROCEDURE

chemoprevention of cancer PROCEDURE

growth factor antagonist therapy PROCEDURE

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Celecoxib; Biological Therapy; Chemoprevention

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

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

• David R. Bickers, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Last Updated: March 22, 2013

Record last verified: 2006-12

Locations

US (1)