Clinical trial · Interventional
Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers
Molecular Targeting of 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancers
NCT00503035CI-TRIAL-00063878completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: * To determine whether celecoxib downregulates GATA-6 expression to upregulate 15-LOX-1 expression and induce apoptosis in human rectal tumors, researchers will measure GATA-6 and 15-LOX-1 expression, 13-S-HODE levels, and apoptosis rates in normal and colorectal polyp epithelial tissues before and after 6 months of celecoxib treatment of patients with familial adenomatous polyposis (FAP).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Colonoscopy Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Celecoxib
- description
- Celecoxib 400 mg orally twice daily for 6 months. Up to 23 additional colon tissue biopsies (the size of a pencil tip), additional 20 minutes on colonoscopy procedure.
- interventionNames
- Drug: Celecoxib
- Procedure: Colonoscopy Biopsy
Primary outcomes (1)
- measure
- 13-HODE Colonic Tissue Levels
- timeFrame
- Baseline to post 6 months of celecoxib treatment
- description
- 13-HODE colonic tissue levels measured by Liquid chromatography and tandem mass spectrometry measurements (LC/MS/MS) in colorectal normal and polyp tissues
Secondary outcomes (1)
- measure
- PGE2 Colonic Tissue Levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria:
1. Diagnosis of familial adenomatous polyposis (patients should have colorectal remnant that can be biopsied. Patients who have had total colorectal surgical resection are not eligible).
2. Adequate bone marrow function (ANC \> 1500 ml, platelet count \> 100,000/ml). Serum creatinine, total bilirubin, and ALT \< 1.5 upper limit normal.
3. Over 16 years of age.
4. Patient is able to give an informed consent.
5. Women of childbearing potential (women are considered to be of childbearing potential unless they are at 2 or more years post-menopausal/or surgically sterile), must:
* Not be pregnant or lactating.
* use adequate contraceptive measures (abstinence, IUD, birth control pills, or diaphragm or condom with spermicidal gel) starting with last menses and throughout the study duration.
* Have a negative serum pregnancy test within 14 days of starting celecoxib.
Exclusion Criteria:
1. Inflammatory bowel disease.
2. Intake of anti-inflammatory medications (e.g., non-steroidal, aspirin, and sulfasalazine) that cannot be discontinued starting 3 days prior to the enrollment.
3. Chemotherapy or radiation therapy in less than three months from the time of enrollment.
4. Individuals who are taking Coumadin that can not be discontinued starting 7 days prior to the enrollment.
5. Individuals who have received an investigational chemopreventive agent during the month prior to the biopsies.
6. History of bleeding diathesis.
7. History of sulfonamides (sulfa) allergies.
8. History of cardiovascular diseases that might include the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.
9. Uncontrolled hypertension (\> 135/\> 85 mm Hg on three repeated measurements during the 6 weeks prior to enrollment on the study).
10. Diagnosis of diabetes.
11. Smoking history during the 6 months prior to enrollment on the study.
12. Uncontrolled hypercholesteremia (low-density lipoprotein cholesterol (LDL-C) \> 130). Hypercholesteremia needs to be controlled following the updated the National Cholesterol Education Program Adult Treatment Panel III Guidelines for at least 3 months prior to enrollment on the study. Hypercholesteremia treatment needs to be continued during the enrollment on the protocol.
13. Family history of premature coronary disease (i.e., onset \< 55 years of age).
14. Metabolic syndrome diagnosis in patients who are 30 years or older. (The diagnosis of metabolic syndrome is made when three or more of these risk factors are present):
* Waist circumference: Men \> 102 cm (\> 40 in); Women \> 88 cm (\> 35 in). \*Triglycerides = 150 mg/dl (= 1.69 mmol/L).
* High-density lipoprotein cholesterol (HDL-C): \[Men \< 40 mg/dl (\< 1.03 mmol/L), Women \<50 mg/dl (\< 1.29 mmol/L)\].
* Blood pressure = 130/= 85 mm Hg.
* Fasting glucose = 110 mg/dl (= 6.1 mmol/L).
15. History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies or prior heparin-induced thrombocytopenia.References
Publications (2)
- BACKGROUNDLynch PM, Morris JS, Ross WA, Rodriguez-Bigas MA, Posadas J, Khalaf R, Weber DM, Sepeda VO, Levin B, Shureiqi I. Global quantitative assessment of the colorectal polyp burden in familial adenomatous polyposis by using a web-based tool. Gastrointest Endosc. 2013 Mar;77(3):455-63. doi: 10.1016/j.gie.2012.11.038. Epub 2013 Jan 18. PMID 23332604
- BACKGROUNDYang P, Zuo X, Advani S, Wei B, Malek J, Day RS, Shureiqi I. Celecoxib Colorectal Bioavailability and Chemopreventive Response in Patients with Familial Adenomatous Polyposis. Cancer Prev Res (Phila). 2022 Apr 1;15(4):217-223. doi: 10.1158/1940-6207.CAPR-21-0066. PMID 34610992