Trial Outcomes & Findings for Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers (NCT NCT00503035)

NCT ID: NCT00503035

Last Updated: 2023-02-13

Results Overview

13-HODE colonic tissue levels measured by Liquid chromatography and tandem mass spectrometry measurements (LC/MS/MS) in colorectal normal and polyp tissues

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Baseline to post 6 months of celecoxib treatment
• Results posted on: 2023-02-13

Participant Flow

51 participants consented, 4 participants were inevaluable.

Participant milestones

Measure	Celecoxib Celecoxib 400 mg orally twice daily for 6 months. Up to 23 colon tissue biopsies (the size of a pencil tip).
Overall Study STARTED	47
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	Celecoxib Celecoxib 400 mg orally twice daily for 6 months. Up to 23 colon tissue biopsies (the size of a pencil tip).
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	3
Overall Study Ineligible	15

Baseline Characteristics

Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers

Baseline characteristics by cohort

Measure	Celecoxib n=29 Participants Celecoxib 400 mg orally twice daily for 6 months. Up to 23 colon tissue biopsies (the size of a pencil tip).
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 13.48 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to post 6 months of celecoxib treatment

13-HODE colonic tissue levels measured by Liquid chromatography and tandem mass spectrometry measurements (LC/MS/MS) in colorectal normal and polyp tissues

Outcome measures

Measure	Celecoxib n=27 Participants Celecoxib 400 mg orally twice daily for 6 months. Up to23 additional colon tissue biopsies (the size of a penciltip), additional 20 minutes on colonoscopy procedure. Celecoxib: 400 mg by mouth twice daily x 6 months Colonoscopy Biopsy: Up to 23 additional colon tissuebiopsies (the size of a pencil tip), additional 20 minuteson colonoscopy procedure
13-HODE Colonic Tissue Levels polyps before celecoxib treatment	14.56 ng/mg tissue protein Standard Deviation 9.93
13-HODE Colonic Tissue Levels polyps after celecoxib treatment	18.83 ng/mg tissue protein Standard Deviation 14
13-HODE Colonic Tissue Levels Normal: before celecoxib treatment	23.02 ng/mg tissue protein Standard Deviation 18.55
13-HODE Colonic Tissue Levels Normal: after celecoxib treatment	20.03 ng/mg tissue protein Standard Deviation 11.7

SECONDARY outcome

Timeframe: at the baseline colonoscopy (or sigmoidoscopy in patients who had undergone colectomy) before the initiation of celecoxib, and the follow-up colonoscopy or sigmoidoscopy was performed after celecoxib treatment (month 6)

PGE2 colonic tissue levels measured by Liquid chromatography and tandem mass spectrometry measurements (LC/MS/MS) in colorectal normal and polyp tissues

Outcome measures

Measure	Celecoxib n=27 Participants Celecoxib 400 mg orally twice daily for 6 months. Up to23 additional colon tissue biopsies (the size of a penciltip), additional 20 minutes on colonoscopy procedure. Celecoxib: 400 mg by mouth twice daily x 6 months Colonoscopy Biopsy: Up to 23 additional colon tissuebiopsies (the size of a pencil tip), additional 20 minuteson colonoscopy procedure
PGE2 Colonic Tissue Levels Polyps: before celecoxib treatment	14.71 ng/mg tissue protein Standard Deviation 6.95
PGE2 Colonic Tissue Levels Polyps: after celecoxib treatment	20.62 ng/mg tissue protein Standard Deviation 10.48
PGE2 Colonic Tissue Levels Normal: before celecoxib treatment	21.48 ng/mg tissue protein Standard Deviation 14.32
PGE2 Colonic Tissue Levels Normal: after celecoxib treatment	24.99 ng/mg tissue protein Standard Deviation 18.25

Adverse Events

Celecoxib

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Celecoxib n=32 participants at risk Celecoxib 400 mg orally twice daily for 6 months. Up to 23 additional colon tissue biopsies
Gastrointestinal disorders Abdominal pain	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Reproductive system and breast disorders Abdominal pain	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.

Other adverse events

Measure	Celecoxib n=32 participants at risk Celecoxib 400 mg orally twice daily for 6 months. Up to 23 additional colon tissue biopsies
Gastrointestinal disorders Abdominal pain	15.6% 5/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Skin and subcutaneous tissue disorders Allergic Reaction	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Anorexia	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Rectal bleeding	12.5% 4/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Eye disorders Blurred vision	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Blood and lymphatic system disorders Bruising	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Constipation	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Cramping	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Diarrhea	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
General disorders Dizziness	9.4% 3/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Dry mouth	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
General disorders Fatigue	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
General disorders Fever	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Flatulance	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Eructation	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Oral Ulceration	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Heartburn	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Rectal hematoma	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Blood and lymphatic system disorders Anemia	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
General disorders Hot flashes	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Increase appetite	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Renal and urinary disorders Bladder infection	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Ear and labyrinth disorders Ear infection	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
General disorders Insomnia	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Skin and subcutaneous tissue disorders Itching	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Nausea	21.9% 7/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
General disorders Night sweats	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Nervous system disorders Headache	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Musculoskeletal and connective tissue disorders Knee pain	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Rectal pain	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Soar throat	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Skin and subcutaneous tissue disorders Boil in left axilla	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
General disorders Left flank pain	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Nervous system disorders Seizure	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Skin and subcutaneous tissue disorders Skin rash	6.2% 2/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Gastrointestinal disorders Vomiting	9.4% 3/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.
Renal and urinary disorders Urinary urgency	3.1% 1/32 • Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months Adverse events accessed for the participants who received celecoxib for any duration on the study.

Additional Information

Dr. Imad Shureiqi, MD

UT MD Anderson Cancer Center

Phone: 713-745-4929

Email: ishureiqi@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place