Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503035
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2007-07-16
Brief Title:
Molecular Targeting of 15-Lipoxygenase-1 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Molecular Targeting of 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancers
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Celecoxib is a drug that was developed to treat arthritis However celecoxib may also help to stop or slow the growth of colon and rectal tumor cells
At the start of the study you will be asked questions about your medical history have a complete physical exam and have around 2 tablespoons of blood drawn for blood tests as part of your routine care for familial adenomatous polyposis Also blood tests such as fasting blood glucose and lipid profiling cholesterol LDL HDL and triglyceride will be assessed to determine eligibility Women who are able to have children must have a negative blood pregnancy test within 14 days of starting celecoxib
Before your scheduled colonoscopy you will fill out a form asking about any medications and nutritional supplements that you are taking In addition you will be asked to complete a diet history This will help researchers to evaluate patients dietary habits The questionnaire takes about 15 minutes to complete You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood Then during your already scheduled colonoscopy procedure you will have additional tissue biopsies the size of a pencil tip of your colon taken For a colonoscopy procedure a flexible tube with a light attached to the end is used to look inside your colonlower gut The biopsies will be taken through the flexible tube using a special cutting tool Up to 23 biopsy samples may be taken The biopsies should take about 20 extra minutes to complete
After the procedure you will start taking celecoxib by mouth once every 12 hours for 6 months You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood at the completion of month 2 and 4 of celecoxib treatment At the end of the 6 month treatment period you will have another colonoscopy procedure This is an additional procedure performed solely for this study and is not part of your standard of care for the treatment of familial adenomatous polyposis A second set of biopsies will be taken 23 maximum These biopsy samples will be studied and compared to the samples taken before treatment with celecoxib You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood
You will be contacted by phone 72 hours after your first dose of celecoxib and then every 2 weeks for the study to check for any side effects you may be experiencing
The maximum amount of time you will remain on this study is 6 months If at any time you experience any intolerable side effects you will be taken off the study
This is an investigational study Celecoxib is FDA approved and commercially available for familial adenomatous polyposis patients to reduce polyp formation Up to 40 patients will take part in this study All will be enrolled at M D Anderson
At the start of the study you will be asked questions about your medical history have a complete physical exam and have around 2 tablespoons of blood drawn for blood tests as part of your routine care for familial adenomatous polyposis Also blood tests such as fasting blood glucose and lipid profiling cholesterol LDL HDL and triglyceride will be assessed to determine eligibility Women who are able to have children must have a negative blood pregnancy test within 14 days of starting celecoxib
Before your scheduled colonoscopy you will fill out a form asking about any medications and nutritional supplements that you are taking In addition you will be asked to complete a diet history This will help researchers to evaluate patients dietary habits The questionnaire takes about 15 minutes to complete You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood Then during your already scheduled colonoscopy procedure you will have additional tissue biopsies the size of a pencil tip of your colon taken For a colonoscopy procedure a flexible tube with a light attached to the end is used to look inside your colonlower gut The biopsies will be taken through the flexible tube using a special cutting tool Up to 23 biopsy samples may be taken The biopsies should take about 20 extra minutes to complete
After the procedure you will start taking celecoxib by mouth once every 12 hours for 6 months You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood at the completion of month 2 and 4 of celecoxib treatment At the end of the 6 month treatment period you will have another colonoscopy procedure This is an additional procedure performed solely for this study and is not part of your standard of care for the treatment of familial adenomatous polyposis A second set of biopsies will be taken 23 maximum These biopsy samples will be studied and compared to the samples taken before treatment with celecoxib You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood
You will be contacted by phone 72 hours after your first dose of celecoxib and then every 2 weeks for the study to check for any side effects you may be experiencing
The maximum amount of time you will remain on this study is 6 months If at any time you experience any intolerable side effects you will be taken off the study
This is an investigational study Celecoxib is FDA approved and commercially available for familial adenomatous polyposis patients to reduce polyp formation Up to 40 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01522 | REGISTRY | None | None |
| 1R01CA106577-01A1 | NIH | NCI CTRP | httpsreporternihgovquickSearch1R01CA106577-01A1 |