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

NCT00087256 | Terminated Phase 3

• 2 other identifiers: NSABP P-3NSABP-P-3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

stage I colon cancer; adenocarcinoma of the colon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Arm 1: placebo

PLACEBO COMPARATOR

one placebo capsule taken orally twice a day for 3 years

Drug: Celecoxib

Arm 2: celecoxib

EXPERIMENTAL

one 400 mg capsule taken orally twice a day for 3 years

Other: placebo

Interventions

Celecoxib DRUG

Also known as: Celebrex

Arm 1: placebo

placebo OTHER

Arm 2: celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15215, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: July 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (1)