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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
placebo
Sponsored by
NSABP Foundation Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring stage I colon cancer, adenocarcinoma of the colon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy At least 10 years Hematopoietic Complete blood count normal Platelet count normal Hepatic Aspartate aminotransferase (AST) normal Bilirubin normal Alkaline phosphatase normal Renal Creatinine normal Cardiovascular 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 Pulmonary No aspirin-sensitive asthma Gastrointestinal No history of inflammatory bowel disease No history of upper gastrointestinal bleeding No history of duodenal or gastric ulcer Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics Other 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

Sites / Locations

  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 1: placebo

Arm 2: celecoxib

Arm Description

one placebo capsule taken orally twice a day for 3 years

one 400 mg capsule taken orally twice a day for 3 years

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To access whether celecoxib will increase disease-free survival.
To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life.
To describe the quality of life in early stage colon cancer patients.
To evaluate if the benefits from celecoxib are more pronounced in a cohort of participants whose primary colon tumors and polyps express COX-2.
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.
To monitor the toxicity and safety of celecoxib in this population.

Full Information

First Posted
July 8, 2004
Last Updated
January 4, 2013
Sponsor
NSABP Foundation Inc
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00087256
Brief Title
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
Official Title
Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
For scientific, logistic, and administrative reasons.
Study Start Date
July 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NSABP Foundation Inc
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary 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. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage I colon cancer, adenocarcinoma of the colon

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: placebo
Arm Type
Placebo Comparator
Arm Description
one placebo capsule taken orally twice a day for 3 years
Arm Title
Arm 2: celecoxib
Arm Type
Experimental
Arm Description
one 400 mg capsule taken orally twice a day for 3 years
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To access whether celecoxib will increase disease-free survival.
Time Frame
60 months
Title
To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life.
Time Frame
60 months
Title
To describe the quality of life in early stage colon cancer patients.
Time Frame
42 months
Title
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
Title
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
Title
To monitor the toxicity and safety of celecoxib in this population.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy At least 10 years Hematopoietic Complete blood count normal Platelet count normal Hepatic Aspartate aminotransferase (AST) normal Bilirubin normal Alkaline phosphatase normal Renal Creatinine normal Cardiovascular 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 Pulmonary No aspirin-sensitive asthma Gastrointestinal No history of inflammatory bowel disease No history of upper gastrointestinal bleeding No history of duodenal or gastric ulcer Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman Wolmark, MD
Organizational Affiliation
NSABP Foundation Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States

12. IPD Sharing Statement

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

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