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Celecoxib in Treating Patients With Familial Adenomatous Polyposis
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2007
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00258219
  Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may stop polyps from forming in patients with familial adenomatous polyposis.

PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with familial adenomatous polyposis.


Condition Intervention
Colorectal Cancer
Precancerous/Nonmalignant Condition
Drug: celecoxib

Genetics Home Reference related topics: familial adenomatous polyposis
MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label
Official Title: Molecular Targeting of 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancer

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

Estimated Enrollment: 40
Study Start Date: November 2002
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the ability of celecoxib to induce apoptosis through the downregulation of GATA-6 expression and upregulation of 15-LOX-1 expression in patients with familial adenomatous polyposis.
  • Determine the amount of GATA-6 and 15-LOX-1 expression, 13-S-HODE levels, and apoptosis rates in normal and colorectal polyp epithelial tissues before and after treatment with this drug in these patients.

OUTLINE: Patients receive oral celecoxib twice daily for 6 months.

Patients also undergo colonoscopy, including a total of 23 colorectal biopsies, once before and after treatment with celecoxib.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of familial adenomatous polyposis

    • Must have a colorectal remnant that can be biopsied

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • No history of bleeding diathesis
  • No family history of protein S or C deficiencies
  • No prior heparin-induced thrombocytopenia

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • ALT < 1.5 times ULN

Renal

  • Creatinine < 1.5 times ULN

Cardiovascular

  • No history of any of the following cardiovascular conditions:

    • Deep venous thrombosis
    • Myocardial infarction
    • Angina
    • Congestive heart failure
    • Stroke
  • No uncontrolled hypertension, defined as blood pressure > 135/85 mm Hg on 3 repeated measurements
  • No uncontrolled hypercholesteremia, defined as low-density lipoprotein cholesterol > 130 mg/dL

    • Hypercholesteremia that has been controlled for ≥ 3 months prior to study entry is allowed
  • No family history of premature coronary disease (i.e., onset < 55 years of age)

Pulmonary

  • No history of pulmonary embolism

Immunologic

  • No history of systemic lupus erythematosus
  • No inflammatory bowel disease
  • No history of allergic reaction to sulfonamides

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No cigarette smoking within the past 6 months
  • No metabolic syndrome, defined by ≥ 3 of the following risk factors:

    • Waist circumference > 102 cm (40 in) for men and > 88 cm (35 in) for women
    • Triglycerides ≥ 150 mg/dL
    • High-density lipoprotein cholesterol < 40 mg/dL for men and < 50 mg/dL for women
    • Blood pressure ≥ 130/85 mm Hg
    • Fasting glucose ≥ 110 mg/dL
  • No diabetes

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • At least 3 months since prior chemotherapy

Radiotherapy

  • At least 3 months since prior radiotherapy

Surgery

  • No prior total colorectal surgical resection
  • No prior coronary bypass surgery
  • No prior coronary angioplasty

Other

  • At least 3 days since prior and no other concurrent anti-inflammatory medications (e.g., non-steroidal anti-inflammatory drugs, aspirin, or sulfasalazine)
  • No concurrent warfarin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258219

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Imad Shureiqi, MD, MS M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000442104, MDA-DM-02592
Study First Received: November 22, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00258219  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer
familial adenomatous polyposis

Study placed in the following topic categories:
Familial adenomatous polyposis
Celecoxib
Digestive System Neoplasms
Precancerous Conditions
Rectal Neoplasms
Adenomatous Polyposis Coli
Gastrointestinal Diseases
Colonic Diseases
Familial polyposis
Polyps
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Genetic Diseases, Inborn
Gastrointestinal Neoplasms
Rectal cancer
Colonic Neoplasms
Adenoma
Colorectal Neoplasms
Adenomatous Polyps
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Intestinal Polyposis
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009