Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
This study has been terminated.
(For scientific, logistic, and administrative reasons.)
Sponsor:
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborator:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00087256
First received: July 8, 2004
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Celecoxib Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
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. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 18 |
| Study Start Date: | July 2004 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm 1: placebo
one placebo capsule taken orally twice a day for 3 years
|
Drug: Celecoxib
Other Name: Celebrex
|
|
Experimental: Arm 2: celecoxib
one 400 mg capsule taken orally twice a day for 3 years
|
Other: placebo |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087256
Locations
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15215 | |
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
| Principal Investigator: | Norman Wolmark, MD | NSABP Foundation, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00087256 History of Changes |
| Other Study ID Numbers: | NSABP P-3, NSABP-P-3 |
| Study First Received: | July 8, 2004 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
|
stage I colon cancer adenocarcinoma of the colon |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Celecoxib Cyclooxygenase 2 Inhibitors |
Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013