Colon Cancer Clinical Trial
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
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.
Full 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Pittsburgh Pennsylvania, 15215, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.