Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

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.

Outcome Time Frame:

60 months

Safety Issue:

Yes

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.

Authority:

United States: Federal Government

Study ID:

NSABP P-3

NCT ID:

NCT00087256

Start Date:

July 2004

Completion Date:

April 2006

Related Keywords:

  • Colorectal Cancer
  • stage I colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772