Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses

NCT00027976 | Withdrawn Phase 2 DMC

• 6 other identifiers: CDR0000069099UAB-9833UAB-NQ401A4009UAB-NQ49902009NCI-P00-0161NCI-P01-0197
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent actinic keratoses. PURPOSE: Randomized phase II/III trial to determine the effectiveness of celecoxib in preventing skin cancer in patients who have actinic keratoses.

Conditions

Precancerous Condition

Keywords

actinic keratosis

Outcome Measures

Primary Outcomes (1)

• Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.

  baseline to 2 months after last dose

Secondary Outcomes (2)

• Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.

  baseline to 2 months after last dose

• Compare the effect of these treatment regimens on potential surrogate end-point biomarkers in areas of actinic keratosis, sun-exposed skin, and non-sun-exposed skin and correlate these biomarkers with clinical outcome in these patients.

  baseline to 2 months after last dose

Study Arms (3)

Group 1 active arm

EXPERIMENTAL

receipt of active drug

Drug: celecoxib

Group 2 active arm

EXPERIMENTAL

receipt of active drug

Drug: celecoxib

group 2 placebo arm

EXPERIMENTAL

receipt of placebo

Drug: Placebo

Interventions

celecoxib DRUG

Group 1 active arm; Group 2 active arm

Placebo DRUG

group 2 placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of Fitzpatrick skin types I, II, or III * Sun-damaged skin with 10-40 actinic keratoses on the upper extremities (upper arms, forearms, and hands), neck, face, and scalp combined PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 125,000/mm\^3 * Hemoglobin at least lower limit of normal * No significant bleeding disorder Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 1.5 times ULN * No chronic or acute hepatic disorder Renal: * Creatinine no greater than 1.5 times ULN * BUN no greater than 1.5 times ULN * No chronic or acute renal disorder Gastrointestinal: * No history of or active inflammatory bowel disease * No active pancreatitis * Not diagnosed with esophageal, gastric, pyloric channel, or duodenal ulceration within the past 30 days Other: * No history of keloid formation * No known photosensitivity disorder * No history of hypersensitivity or adverse reaction to sulfonamides, COX-2 inhibitors, salicylates, or other NSAIDs * No other condition that would preclude study * No other medical or psychosocial condition that would preclude study * No other malignancy within the past 5 years except: * Carcinoma in situ of the cervix * Curatively excised nonmelanoma skin cancer * Stage 0 chronic lymphocytic leukemia * Any cancer for which the patient is currently without evidence of disease, has not been treated for tumor within the past 6 months, has no current or planned therapy, and has an expected disease-free survival of at least 5 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 30 days since prior systemic immunotherapy * No concurrent immunotherapy Chemotherapy: * At least 3 months since prior topical fluorouracil (5-FU) * At least 6 months since other prior topical chemotherapy * No concurrent topical chemotherapy, including 5-FU * No other concurrent chemotherapy Endocrine therapy: * At least 6 months since prior oral or IV corticosteroids for more than 2 consecutive weeks * At least 6 months since prior inhaled or nasal corticosteroids for more than 4 weeks duration * At least 14 days since prior topical corticosteroids * At least 30 days since prior nasal corticosteroids (except mometasone) * No concurrent oral or IV corticosteroids for more than 2 consecutive weeks during any 6 month period during study * No concurrent inhaled or nasal steroids (except mometasone) for more than 4 weeks during any 6 month period during study * No concurrent hormonal or steroidal therapy, including topical corticosteroids * Concurrent hormone replacement therapy (e.g., estrogen or thyroid hormone replacement) allowed Radiotherapy: * At least 6 months since prior local radiotherapy to areas being studied * At least 30 days since other prior radiotherapy * No concurrent radiotherapy, including local radiotherapy to areas being studied Surgery: * Not specified Other: * At least 30 days since prior cryotherapy to target lesions * At least 60 days since prior laser resurfacing, dermabrasion, or chemical peels * At least 30 days since prior investigational medication * At least 14 days since prior topical alphahydroxyacids (e.g., glycolic acid or lactic acid) or retinoids * At least 30 days since prior systemic psoralens or retinoids * At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulcers * At least 30 days since prior aspirin (more than 100 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors at a frequency of at least 3 times per week for more than 2 weeks (except cardioprotective doses of aspirin (no more than 100 mg/day) * No concurrent systemic psoralens or retinoids * No concurrent prescription or over-the-counter topical medications to areas being studied (e.g., vitamin A derivatives) * No concurrent cryotherapy to target lesions * No concurrent laser resurfacing, dermabrasion, or chemical peels * No other concurrent investigational medications * No concurrent fluconazole or lithium * No concurrent chronic NSAIDs or COX-2 inhibitors (at least 3 times per week for more than 2 consecutive weeks per year) * Concurrent cardioprotective doses of oral aspirin (100 mg per day or less) allowed * Concurrent moisturizer/emollient or sunscreen allowed

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Irvine, California, 92697, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0314, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Related Publications (2)

• Elmets CA, Viner JL, Pentland AP, Cantrell W, Lin HY, Bailey H, Kang S, Linden KG, Heffernan M, Duvic M, Richmond E, Elewski BE, Umar A, Bell W, Gordon GB. Chemoprevention of nonmelanoma skin cancer with celecoxib: a randomized, double-blind, placebo-controlled trial. J Natl Cancer Inst. 2010 Dec 15;102(24):1835-44. doi: 10.1093/jnci/djq442. Epub 2010 Nov 29.

  PMID: 21115882 RESULT

• Bakshi A, Shafi R, Nelson J, Cantrell WC, Subhadarshani S, Andea A, Athar M, Elmets CA. The clinical course of actinic keratosis correlates with underlying molecular mechanisms. Br J Dermatol. 2020 Apr;182(4):995-1002. doi: 10.1111/bjd.18338. Epub 2019 Sep 11.

  PMID: 31299087 DERIVED

MeSH Terms

Conditions

Precancerous Conditions; Keratosis, Actinic

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

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

Study Officials

• Craig A. Elmets, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 2001
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 5, 2013

Record last verified: 2012-11

Locations

US (7)