Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052611
First received: January 24, 2003
Last updated: July 23, 2008
Last verified: January 2005
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing head and neck cancer in patients who have oral leukoplakia or head and neck dysplasia.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.


Condition Intervention Phase
Head and Neck Cancer
Drug: celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Prevention
Official Title: Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study

Resource links provided by NLM:


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

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the response rate, in terms of prostaglandin E2 expression, in patients with oral leukoplakia and/or dysplasia treated with celecoxib.
  • Determine the change in other biomarkers including COX-2, Ak+, Ki-67, BCL2, BAX, VEGF, and CD31, in patients treated with this drug.
  • Determine the efficacy of this drug, in terms of reducing the size of oral leukoplakia lesions and presence of dysplasia, in these patients.
  • Correlate change in biomarker expression with response of oral leukoplakia lesions and/or dysplasia in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a repeat biopsy. Patients with a positive response receive celecoxib for an additional 9 months.

Patients are followed every 3-6 months for 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Oral leukoplakia on clinical examination AND/OR
  • More than one prior squamous cell carcinoma (SCC) of the head and neck and dysplasia on biopsy within the past 6 months
  • Carcinoma in situ or new leukoplakia eligible provided treatment for a prior carcinoma was completed more than 9 months ago

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 months

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Transaminases less than 1.5 times ULN
  • PT/PTT less than 1.5 times ULN
  • No acute or chronic liver disease

Renal

  • Creatinine less than 1.5 times ULN
  • Urine protein less than 2+
  • No acute or chronic renal insufficiency

Cardiovascular

  • No New York Heart Association class II congestive heart failure
  • No prior myocardial infarction
  • No angina
  • No known coronary artery disease

Pulmonary

  • No advanced chronic obstructive pulmonary disease requiring home oxygen use

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No infection within the past 2 weeks
  • No concurrent infection
  • No concurrent tobacco use (e.g., cigarette, cigar, pipe, or chewing tobacco)

    • At least 1 month since prior use
  • No active alcohol abuse
  • No history of gastrointestinal ulcer
  • No history of anaphylactoid reaction to aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
  • No concurrent active malignancy except non-melanoma skin cancer
  • No contraindication to nasopharyngoscopy and biopsy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • More than 3 months since prior absorbed steroids, including inhaled and nasal steroids (3 times a week for at least 2 consecutive weeks)

    • Prior mometasone allowed

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Prior surgery for SCC of the head and neck allowed provided patient has been cancer free for at least 9 months

Other

  • More than 3 months since prior full-dose aspirin, COX-2 inhibitors, or NSAIDs (at least 3 times a week for at least 2 weeks)
  • More than 3 months since prior retinoids or selenium
  • No concurrent lithium or fluconazole
  • No concurrent diuretics for congestive heart failure
  • No concurrent angiotensin-converting enzyme inhibitors
  • Concurrent aspirin allowed if dosage no greater than 81 mg per day
  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: NCT00052611

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Lori J. Wirth, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00052611     History of Changes
Other Study ID Numbers: CDR0000258562, DFCI-02024, DFCI-2002-P-00150/2
Study First Received: January 24, 2003
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
lip and oral cavity cancer
paranasal sinus and nasal cavity cancer
hypopharyngeal cancer
laryngeal cancer
oropharyngeal cancer
nasopharyngeal cancer
salivary gland cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Leukoplakia, Oral
Neoplasms by Site
Neoplasms
Mouth Neoplasms
Leukoplakia
Precancerous Conditions
Mouth Diseases
Stomatognathic Diseases
Pathological Conditions, Anatomical
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 29, 2014