UAB 0040

A Randomized, Placebo-Controlled, Phase IIB Evaluation of Cyclooxygenase - 2 Activity in Surgically Resected Primary Colorectal Adenomas and Carcinomas after 7 Days Pretreatment with Celecoxib.

Sponsor: UAB and Pharmacia

Principal Investigator: Martin J. Heslin, M.D.

Objective

To determine if celecoxib is capable of inhibiting activity of the enzymes involved in both the development of adenomatous polyps and the progression of adenomatous polyps to cancer.

Patient Selection Criteria

Inclusion Criteria

1. Males and females of any racial and ethnic group who are 18 years of age or older.



2. Presence of a mass suspicious for carcinoma or a biopsy-proven colorectal carcinoma, or presence of an adenomatous polyp that is nonresectable by colonoscopy.



3. KPS > 60.

Exclusion Criteria

1. Severe infection (increased white blood cell count, fever, sepsis)



2. Suppressed immune function (steroids, transplant patient)



3. Emergent operation required due to perforation or obstruction



4. Lab values revealing either total bilirubin or cratinine greater than two times the normal upper limit of normal would be excluded.



5. Pregnant or women who are breastfeeding or subjects of child bearing age who do not practice effective means of birth control.

Additional Information

For further information, contact Jill Weingarten, RN, OCN at (205) 975-0450