Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Celecoxib

Criteria

DISEASE CHARACTERISTICS:

• Age 18 to 49 with one of the following colorectal abnormalities:

• At least one adenoma that is at least 1 cm

• At least 3 adenomas of any size with at least 5 rectal aberrant crypt foci (ACFs)

• Age 50 and over with one of the following colorectal abnormalities:

• At least one adenoma that is at least 5 mm and at least 5 rectal ACFs

• History of polyps (at least 1 adenoma) within the past 5 years

• No history of germline cancer syndrome

• No stage III or IV colorectal cancer (Dukes' C or D) diagnosed within the past 6 months

• No current colorectal cancer

• No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)

PATIENT CHARACTERISTICS:

Age

• See Disease Characteristics

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin greater than 11.5 g/dL

• WBC greater than 3,000/mm^3

• Platelet count greater than 125,000/mm^3

• No significant bleeding disorder

Hepatic

• AST and ALT no greater than 1.5 times upper limit of normal (ULN)

• Bilirubin no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 1.5 times ULN

• No chronic or acute hepatic disorder

Renal

• Creatinine no greater than 1.5 times ULN

• No chronic or acute renal disorder

Cardiovascular

• No uncontrolled hypertension

• No unstable angina

• No congestive heart failure

Pulmonary

• No asthma

• No severe chronic obstructive pulmonary disease

Gastrointestinal

• No active gastrointestinal ulcers

• No history of peptic ulcer disease

Other

• No prior hypersensitivity reaction to NSAIDs, aspirin, or sulfa drugs

• No medical contraindication to NSAID use

• Not pregnant or nursing

• Negative pregnancy test

• Fertile female patients must use effective contraception

• No known allergic reaction to indigo carmine

• No other clinically significant medical condition or abnormal laboratory value that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Anticipated use of corticosteroids less than 2 weeks over 6 months

• Anticipated use of mometasone less than 4 weeks over 6 months

• No other concurrent inhaled steroids for 30 days before or during study participation

Radiotherapy

• No prior pelvic radiotherapy

Surgery

• Not specified

Other

• More than 30 days since prior investigational drugs

• No prior participation in this study

• No regular nonsteroidal anti-inflammatory drug (NSAID) or aspirin use (average of 3 or more doses per week for at least 3 months) except low-dose aspirin for cardiovascular disease prophylaxis

• No other concurrent investigational drugs

• No concurrent fluconazole or lithium