Phase 2
N=47
Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal Cancers
Familial Adenomatous Polyposis
Bottom Line
View on ClinicalTrials.gov: NCT00503035 ↗Enrolled (actual)
47
Serious AEs
6.3%
Results posted
Feb 2023
Primary outcome: Primary: 13-HODE Colonic Tissue Levels — 14.56; 18.83; 23.02; 20.03 ng/mg tissue protein
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Celecoxib (Drug); Colonoscopy Biopsy (Procedure)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 13-HODE Colonic Tissue Levels |
14.56; 18.83; 23.02; 20.03 | — |
| SECONDARY PGE2 Colonic Tissue Levels |
14.71; 20.62; 21.48; 24.99 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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).
- Adequate bone marrow function (ANC > 1500 ml, platelet count > 100,000/ml). Serum creatinine, total bilirubin, and ALT 135/> 85 mm Hg on three repeated measurements during the 6 weeks prior to enrollment on the study).
- Diagnosis of diabetes.
- Smoking history during the 6 months prior to enrollment on the study.
- 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.
- Family history of premature coronary disease (i.e., onset 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).
- History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies or prior heparin-induced thrombocytopenia.
Data sourced from ClinicalTrials.gov (NCT00503035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.