Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
- Registration Number
- NCT00087256
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: celecoxib placebo one 400 mg capsule taken orally twice a day for 3 years Arm 1: placebo Celecoxib one placebo capsule taken orally twice a day for 3 years
- Primary Outcome Measures
Name Time Method 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. 60 months
- Secondary Outcome Measures
Name Time Method To access whether celecoxib will increase disease-free survival. 60 months To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life. 60 months To describe the quality of life in early stage colon cancer patients. 42 months To evaluate if the benefits from celecoxib are more pronounced in a cohort of participants whose primary colon tumors and polyps express COX-2. 60 months 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. 60 months To monitor the toxicity and safety of celecoxib in this population. 60 months
Trial Locations
- Locations (1)
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States