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Celecoxib in Preventing Skin Cancer

Primary Purpose

Non-melanomatous Skin Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
anti-cytokine therapy
antiangiogenesis therapy
biological therapy
cancer prevention intervention
chemoprevention of cancer
growth factor antagonist therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
March 21, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00025051
Brief Title
Celecoxib in Preventing Skin Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanomatous Skin Cancer
Keywords
basal cell carcinoma of the skin, squamous cell carcinoma of the skin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Procedure
Intervention Name(s)
anti-cytokine therapy
Intervention Type
Procedure
Intervention Name(s)
antiangiogenesis therapy
Intervention Type
Procedure
Intervention Name(s)
biological therapy
Intervention Type
Procedure
Intervention Name(s)
cancer prevention intervention
Intervention Type
Procedure
Intervention Name(s)
chemoprevention of cancer
Intervention Type
Procedure
Intervention Name(s)
growth factor antagonist therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Bickers, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Celecoxib in Preventing Skin Cancer

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