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Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer

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: NCT00087256
Recruitment Status : Terminated (For scientific, logistic, and administrative reasons.)
First Posted : July 12, 2004
Last Update Posted : January 7, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known whether celecoxib is effective in preventing polyps in patients with colon cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of celecoxib in preventing the development of polyps in patients who have undergone surgery for stage I colon cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Celecoxib Other: placebo Phase 3

Detailed Description:



  • Compare celecoxib vs placebo, in terms of decreasing the incidence of adenomatous polyps of the colon and rectum, in patients with resected stage I adenocarcinoma of the colon.


  • Compare disease-free survival of patients treated with these regimens.
  • Compare the effect of these regimens on self-reported symptoms and health-related quality of life of these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the benefits of celecoxib in patients with primary tumors or polyps that express cyclo-oxygenase-2 (COX-2) with those that do not express COX-2.
  • Compare the expression of signaling targets such as serine/threonine AKT, extracellular signal-regulated kinase 2 (ERK2), and endoplasmic reticulum Ca+2- ATPases in the index tumor and polyps.
  • Determine the toxicity and safety of celecoxib in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, tumor stage (T1 vs T2), age (≤ 49 vs 50 to 59 vs ≥ 60 years), and current aspirin use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral celecoxib twice daily for 3 years.
  • Arm II: Patients receive oral placebo twice daily for 3 years. In both arms, treatment continues in the absence of unacceptable toxicity or the diagnosis of invasive colon cancer, carcinoma in situ of the colon or rectum, or a non-colon primary cancer.

Quality of life is assessed at baseline and then at 6, 12, 24, 36, and 42 months.

Patients are followed at 6 months and at 2 years.

PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 2.5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
Study Start Date : July 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Placebo Comparator: Arm 1: placebo
one placebo capsule taken orally twice a day for 3 years
Drug: Celecoxib
Other Name: Celebrex

Experimental: Arm 2: celecoxib
one 400 mg capsule taken orally twice a day for 3 years
Other: placebo

Primary Outcome Measures :
  1. To determine whether celecoxib 400 mg bid for 3 years will decrease the incidence of adenomatous polyps of the colon and rectum in participants with Stage I adenocarcinoma of the colon. [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. To access whether celecoxib will increase disease-free survival. [ Time Frame: 60 months ]
  2. To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life. [ Time Frame: 60 months ]
  3. To describe the quality of life in early stage colon cancer patients. [ Time Frame: 42 months ]
  4. To evaluate if the benefits from celecoxib are more pronounced in a cohort of participants whose primary colon tumors and polyps express COX-2. [ Time Frame: 60 months ]
  5. To examine the expression of signaling targets such as serine/threonine kinase (AKT) extracellular signal-regulated kinase (ERK2), and endoplasmic reticulum Ca2+-ATPases in the index tumor and polyps. [ Time Frame: 60 months ]
  6. To monitor the toxicity and safety of celecoxib in this population. [ Time Frame: 60 months ]

Information from the National Library of Medicine

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


  • Histologically confirmed adenocarcinoma of the colon

    • Stage I disease
    • Distal border of tumor ≥ 12 cm from the anal verge
  • Tumor completely resected within the past 90 days
  • Must have undergone a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) within the past 90 days

    • All observed polyps must have been removed
  • Patients with a history suggestive of hereditary non-polyposis colorectal cancer (HNPCC) must have a normal microsatellite instability status by immunohistochemistry or polymerase chain reaction

    • Patients with family history of colon cancer who have not been diagnosed with HNPCC are eligible
  • No prior familial adenomatous polyposis
  • No prior invasive cancer or carcinoma in situ of the colon or rectum
  • No clinical or radiologic evidence of metastatic disease



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • At least 10 years


  • Complete blood count normal
  • Platelet count normal


  • Aspartate aminotransferase (AST) normal
  • Bilirubin normal
  • Alkaline phosphatase normal


  • Creatinine normal


  • No active ischemic heart disease
  • No New York Heart Association class III or IV heart disease
  • No myocardial infarction within the past 6 months
  • No symptomatic arrhythmia
  • No symptomatic peripheral vascular disease or carotid disease that would preclude study participation


  • No aspirin-sensitive asthma


  • No history of inflammatory bowel disease
  • No history of upper gastrointestinal bleeding
  • No history of duodenal or gastric ulcer


  • No known hypersensitivity to any COX-2 inhibitor, NSAIDs, aspirin, or sulfonamides
  • No non-colorectal malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer
  • No other disease that would preclude study participation
  • No psychiatric disorders, including history of clinical depression or addictive disorders, that would preclude giving informed consent or long-term compliance
  • No rheumatologic or skeletal disorders requiring chronic NSAIDs or steroid therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics


  • No other concurrent investigational agents for colon cancer
  • No concurrent chronic use of other cyclo-oxygenase-2 (COX-2) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or salicylates (e.g., aspirin)

    • Chronic use is defined as use for more than an average of 3 days per month

      • Concurrent NSAIDs allowed for up to 10 consecutive days for temporary relief due to inflammatory syndromes, injury, or postoperative pain
    • Cardioprotective doses of aspirin (≤ 81 mg/day or 325 mg every other day) allowed
  • No concurrent fluconazole or lithium

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): NCT00087256

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United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15215
Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
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Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
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Responsible Party: NSABP Foundation Inc Identifier: NCT00087256    
Other Study ID Numbers: NSABP P-3
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013
Keywords provided by NSABP Foundation Inc:
stage I colon cancer
adenocarcinoma of the colon
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action