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Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer

Information source: NSABP Foundation Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: Celecoxib (Drug); placebo (Other)

Phase: Phase 3

Status: Terminated

Sponsored by: NSABP Foundation Inc

Official(s) and/or principal investigator(s):
Norman Wolmark, MD, Principal Investigator, Affiliation: NSABP Foundation Inc

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.

Clinical Details

Official title: Celecoxib Polyp Prevention Trial in Participants With Resected 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

Primary outcome: 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.

Secondary outcome:

To access whether celecoxib will increase disease-free survival.

To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life.

To describe the quality of life in early stage colon cancer patients.

To evaluate if the benefits from celecoxib are more pronounced in a cohort of participants whose primary colon tumors and polyps express COX-2.

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.

To monitor the toxicity and safety of celecoxib in this population.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Allegheny General Hospital, Pittsburgh, Pennsylvania 15215, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2004
Last updated: January 4, 2013

Page last updated: August 20, 2015

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