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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023621
First received: September 13, 2001
Last updated: June 25, 2013
Last verified: July 2007
  Purpose

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 Intervention Phase
Non-melanomatous Skin Cancer
Drug: celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prevention of the development of basal cell carcinoma [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2001
Study Completion Date: July 2007
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

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

Renal:

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

Cardiovascular:

  • No congestive heart failure

Gastrointestinal:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023621

Locations
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
Investigators
Study Chair: Ervin Epstein, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00023621     History of Changes
Other Study ID Numbers: UCSF-U19-CA81888-BC, CDR0000068817, UCSF-H473-16531-02B, NCI-P01-0190
Study First Received: September 13, 2001
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
basal cell carcinoma of the skin

Additional relevant MeSH terms:
Basal Cell Nevus Syndrome
Skin Neoplasms
Carcinoma, Basal Cell
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Cysts
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Neoplasms by Site
Skin Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on August 27, 2014