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 develpment of adenomatous
polyps and the progression of adenomatous polyps to cancer.
PATIENT
SELECTION CRITERIA
Inclusion
Criteria
- Males and
females of any racial and ethnic group who are 18 years
of age or older.
- Presence of
a mass suspicious for carcinoma or a biopsy-proven colorectal
carcinoma, or presence of an adenomatous polyp that is
nonresectable by colonoscopy.
- KPS >
60.
Exclusion
Criteria
- Severe infection
(increased white blood cell count, fever, sepsis)
- Suppressed
immune function (steroids, transplant patient)
- Emergent operation
required due to perforation or obstruction
- Lab values
revealing either total bilirubin or cratinine greater
than two times the normal upper limit of normal would
be excluded.
- Pregnant or
woumen 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
