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Non-melanomatous Skin CancerPhase 2NCT00025051

Celecoxib in Preventing Skin Cancer

A Phase 2 study testing celecoxib, anti-cytokine therapy and antiangiogenesis therapy in people with Non-melanomatous Skin Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Non-melanomatous Skin Cancer
What is being tested?
celecoxib, anti-cytokine therapy and antiangiogenesis therapy
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
celecoxib, anti-cytokine therapy, antiangiogenesis therapy, biological therapy, cancer prevention intervention
Keywords
basal cell carcinoma of the skin, squamous cell carcinoma of the skin
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • celecoxibDrug

  • anti-cytokine therapyProcedure or surgery

  • antiangiogenesis therapyProcedure or surgery

  • biological therapyProcedure or surgery

  • cancer prevention interventionProcedure or surgery

  • chemoprevention of cancerProcedure or surgery

  • growth factor antagonist therapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025051
Sponsor's protocol ID
CDR0000068840
Other IDs
CPMC-U19-CA81888-01-UV, CPMC-IRB-9923, NCI-P01-0191
Status last verified
Dec 2006
First submitted
11 Oct 2001
Last updated
22 Mar 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing celecoxib, anti-cytokine therapy and antiangiogenesis therapy in people with Non-melanomatous Skin Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.

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