Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
60 months
Safety Issue:
Yes
Principal Investigator
Norman Wolmark, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NSABP Foundation, Inc.
Authority:
United States: Federal Government
Study ID:
NSABP P-3
NCT ID:
NCT00087256
Start Date:
July 2004
Completion Date:
April 2006
Related Keywords:
- Colorectal Cancer
- stage I colon cancer
- adenocarcinoma of the colon
- Colonic Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
