Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer|
- 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 ] [ Designated as safety issue: Yes ]
- To access whether celecoxib will increase disease-free survival. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
- To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life. [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- To describe the quality of life in early stage colon cancer patients. [ Time Frame: 42 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- To monitor the toxicity and safety of celecoxib in this population. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2004|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Placebo Comparator: Arm 1: placebo
one placebo capsule taken orally twice a day for 3 years
Other Name: Celebrex
Experimental: Arm 2: celecoxib
one 400 mg capsule taken orally twice a day for 3 years
- 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.
|United States, Pennsylvania|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15215|
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation, Inc.|