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Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses

Primary Purpose

Precancerous Condition

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Precancerous Condition focused on measuring actinic keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • University of Texas - MD Anderson Cancer Center
  • University of Wisconsin Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1 active arm

Group 2 active arm

group 2 placebo arm

Arm Description

receipt of active drug

receipt of active drug

receipt of placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 7, 2001
Last Updated
August 1, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00027976
Brief Title
Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
Official Title
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Study Start Date
December 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Condition
Keywords
actinic keratosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 active arm
Arm Type
Experimental
Arm Description
receipt of active drug
Arm Title
Group 2 active arm
Arm Type
Experimental
Arm Description
receipt of active drug
Arm Title
group 2 placebo arm
Arm Type
Experimental
Arm Description
receipt of placebo
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
Time Frame
baseline to 2 months after last dose
Secondary Outcome Measure Information:
Title
Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.
Time Frame
baseline to 2 months after last dose
Title
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.
Time Frame
baseline to 2 months after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig A. Elmets, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0314
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21115882
Citation
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.
Results Reference
result
PubMed Identifier
31299087
Citation
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.
Results Reference
derived

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Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses

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