Trial Outcomes & Findings for Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib (NCT NCT00582660)

Results Overview

The Colo-Rectal adenocarcinoma will be measured by cyclooxygenase-2(COX-2) activity at 7 days post baseline. Cox-2 activity is measured by assessing tumors and normal tissue using "Electron microscope and Tandem mass Spectrometry" methodology though the UAB shared Mass Spectrometry facility. Improvement was measured by 2-fold increase in COX-2 activity from baseline. The methodology used was High Performance Liquid Chromatography(HPLC). additional studies include expression of genes thought to be important in colorectal carcinogenesis: COX-1 and 2, MMP, 2 7, and 9, tissue inhibitor of metalloproteinases(TIMPs) 1 ans 2 and beta-catenin.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

baseline to 7 days

Results posted on

2017-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Celecoxib 400 mg BID given for 7 days before surgery	Placebo 1 tablet BID given for 7 days before surgery
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib n=20 Participants 400 mg BID given for 7 days before surgery	Placebo n=20 Participants 1 tablet BID given for 7 days before surgery	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 1 • n=5 Participants	62 years STANDARD_DEVIATION 1 • n=7 Participants	62 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 7 days

The Colo-Rectal adenocarcinoma will be measured by cyclooxygenase-2(COX-2) activity at 7 days post baseline. Cox-2 activity is measured by assessing tumors and normal tissue using "Electron microscope and Tandem mass Spectrometry" methodology though the UAB shared Mass Spectrometry facility. Improvement was measured by 2-fold increase in COX-2 activity from baseline. The methodology used was High Performance Liquid Chromatography(HPLC). additional studies include expression of genes thought to be important in colorectal carcinogenesis: COX-1 and 2, MMP, 2 7, and 9, tissue inhibitor of metalloproteinases(TIMPs) 1 ans 2 and beta-catenin.

Outcome measures

Outcome measures
Measure	Celecoxib n=20 Participants 400 mg BID given for 7 days before surgery	Placebo n=20 Participants 1 tablet BID given for 7 days before surgery
Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib	2.0 Participant	2.0 Participant

PRIMARY outcome

Timeframe: baseline to 72 hours

At 72 hours after start of treatment, the number of subjects with immunoblot demonstrated a 1.5 to 2 fold increase in 15-LOX-1 protein expression in human colorectal adenocarcinoma cell line with epithelial morphology(HT-29) and dihydrolipoamide dehydrogenase(DLD)-1 cells.

Outcome measures

Outcome measures
Measure	Celecoxib n=20 Participants 400 mg BID given for 7 days before surgery	Placebo n=20 Participants 1 tablet BID given for 7 days before surgery
Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot	3.0 Participants 0.5	0 Participants 0.5

Adverse Events

Celecoxib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martin J. Heslin M.D.

University of Alabama at Birmingham

Phone: 205-975-0450

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place