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Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023621
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the development of basal cell carcinoma.

PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome.

Condition or disease Intervention/treatment Phase
Non-melanomatous Skin Cancer Drug: celecoxib Phase 2

Detailed Description:


  • Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive oral celecoxib twice daily.
  • Arm II: Patients receive oral placebo twice daily. Treatment continues for 2 years in the absence of unacceptable toxicity.

Patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome
Study Start Date : February 2001
Actual Study Completion Date : July 2007

Primary Outcome Measures :
  1. Prevention of the development of basal cell carcinoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed basal cell carcinoma (BCC)

    • At least 5 prior BCCs AND
    • At least 4 BCCs within the past year
  • Meets diagnostic criteria for basal cell nevus syndrome (BCNS)

    • Any 1 of the following:

      • More than 2 BCCs or 1 before age 20
      • Histologically confirmed odontogenic keratocysts of the jaw
      • 3 or more palmar and/or plantar pits
      • Bilamellar calcification of the falx cerebri (if less than 20 years of age)
      • Fused, bifid, or markedly splayed ribs
      • First degree relative with BCNS
      • PTC gene mutation in normal tissue OR
    • Any 2 of the following:

      • Macrocephaly determined after adjustment for height
      • Congenital malformations (e.g., cleft lip or palate, frontal bossing, "coarse face", or moderate or severe hypertelorism)
      • Skeletal abnormalities (e.g., Sprengel deformity, marked pectus deformity, or marked syndactyly of the digits)
      • Radiological abnormalities (e.g., bridging of the sella turcica, vertebral anomalies, modeling defects of the hands and feet, or flame-shaped lucencies of the hands or feet)
      • Ovarian fibroma
      • Medulloblastoma



  • 18 to 75

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm^3
  • Platelet count greater than 125,000/mm^3
  • Hemoglobin greater than 12.0 g/dL (women)
  • Hemoglobin greater than 13.0 g/dL (men)
  • No significant coagulation defect


  • Bilirubin normal
  • ALT/AST no greater than 1.5 times upper limit of normal (ULN)
  • No chronic or acute hepatic disorder


  • Creatinine no greater than 1.5 times ULN
  • BUN normal
  • Electrolytes within normal
  • No chronic or acute renal disorder


  • No congestive heart failure


  • No active gastrointestinal disease
  • No inflammatory bowel disease
  • No chronic or acute pancreatic disorder
  • No history of gastrointestinal ulceration allowed except with permission of primary care physician
  • No esophageal, gastric, pyloric channel, or duodenal ulceration within the past 30 days
  • Stool hematest normal


  • No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer, stage I cervical cancer, stage 0 chronic lymphoblastic leukemia, or medulloblastoma
  • No hypersensitivity to COX-2 inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides
  • No other condition that would preclude study involvement
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • At least 2 weeks since prior topical agents as chemoprevention
  • At least 1 year since other prior chemotherapy

Endocrine therapy:

  • At least 1 month since prior oral or IV corticosteroids
  • At least 6 months since prior inhaled corticosteroid use for longer than 4 weeks
  • At least 2 weeks since prior topical glucocorticoids
  • No concurrent topical glucocorticoids
  • Concurrent oral and IV corticosteroid use of less than 2 weeks within 6 months allowed
  • Concurrent inhaled corticosteroid use of less than 4 weeks within 6 months allowed


  • Not specified


  • Not specified


  • At least 2 weeks since prior topical retinoids or alpha-hydroxy acids (e.g., glycolic acid or lactic acid)
  • At least 2 weeks since prior topical medications
  • At least 30 days since prior investigational agents
  • At least 2 months since prior NSAIDs given more than 3 times/week
  • At least 2 months since prior aspirin dose of more than 100 mg/day given more than 3 times/week
  • At least 6 months since prior oral retinoids
  • No concurrent chronic NSAIDs (more than 3 times per week for at least 2 weeks)
  • No concurrent aspirin dose of more than 100 mg/day
  • No concurrent topical medications
  • No concurrent fluconazole
  • No concurrent lithium
  • No concurrent retinoids (including topical administration) or alpha-hydroxy acids
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023621

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United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
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Study Chair: Ervin Epstein, MD University of California, San Francisco
Publications of Results:
Layout table for additonal information Identifier: NCT00023621    
Other Study ID Numbers: UCSF-U19-CA81888-BC
CDR0000068817 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: July 2007
Keywords provided by National Cancer Institute (NCI):
basal cell carcinoma of the skin
Additional relevant MeSH terms:
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Skin Neoplasms
Basal Cell Nevus Syndrome
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs