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- Klinische proef NCT00027976
Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
- Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
- Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.
- Determine the safety of this drug in these patients.
- 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.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily for 9 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo as in arm I. Patients are followed at 2 months after completing treatment.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study.
Studietype
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Irvine, California, Verenigde Staten, 92697
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109-0314
- University of Michigan Comprehensive Cancer Center
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Missouri
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Saint Louis, Missouri, Verenigde Staten, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New York
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Rochester, New York, Verenigde Staten, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Texas
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Houston, Texas, Verenigde Staten, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Group 1 active arm
receipt of active drug
|
|
Experimenteel: Group 2 active arm
receipt of active drug
|
|
Experimenteel: group 2 placebo arm
receipt of placebo
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
Tijdsspanne: baseline to 2 months after last dose
|
baseline to 2 months after last dose
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.
Tijdsspanne: baseline to 2 months after last dose
|
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.
Tijdsspanne: baseline to 2 months after last dose
|
baseline to 2 months after last dose
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Craig A. Elmets, MD, University of Alabama at Birmingham
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Neoplasmata
- Keratose, actinische
- Keratose
- Voorstadia van kanker
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Cyclo-oxygenaseremmers
- Cyclo-oxygenase 2-remmers
- Celecoxib
Andere studie-ID-nummers
- CDR0000069099
- UAB-9833
- UAB-NQ401A4009
- UAB-NQ49902009
- NCI-P00-0161
- NCI-P01-0197
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