Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00233935
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2005-10-05
Brief Title:
Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barretts Esophagus
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase Ib Randomized Double-Blinded Placebo-Controlled Dose Escalation Study of Polyphenon E in Patients With Barretts Esophagus
Status:
COMPLETED
Status Verified Date:
2013-04
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:
The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels Researchers also want to find out what effects good and bad it may have on individual and their risk for esophagus cancer Esophagus cancer is an increased risk associated with Barretts esophagus Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of defined green tea catechin extract may prevent esophageal cancer
Detailed Description:
PRIMARY OBJECTIVES
I The primary objective of this study is to demonstrate the safety ie determine the maximum tolerated dose MTD of using Polyphenon E Poly E over a six-month period in the management of patients with Barretts Esophagus BE with or without low-grade dysplasia LGD
SECONDARY OBJECTIVES
I To investigate the dose-related biologic effects and pharmacodynamic properties of Poly E in order of decreasing priority
II Determine the efficacy of Poly E in inhibiting phosphorylation of EGFR or Her-2 or akt in esophageal mucosa
III Determine the pharmacodynamic profile of Poly E constituents EGCG EGC EC in esophageal tissue during and after 6 months of therapy using HPLC and GC-MS
IV Evaluate the efficacy of Poly E in reducing or stabilizing metaplasia and dysplasia of esophageal Barretts mucosa using visual endoscopic measurements and histological analysis
V Determine the efficacy of Poly E in modulating surrogate biomarkers in esophageal mucosa - degrees of tetraploidy and aneuploidy expression of cyclin D1 COX-2 EGFR Her-2 akt and Ki-67 LOH at 9p p16 and 17p p53 apoptotic index
VI Determine the efficacy of Poly E in inhibiting methylation of p16 VII Determine the efficacy of Poly E in modulating eicosanoid levels including PGE2 and lipoxygenase profiles in esophageal mucosa
The esophagus is the tube used for swallowing that connects the mouth to the stomach Barretts esophagus is a condition in which the tissue lining of the esophagus is abnormal It develops in some people who have heartburn reflux disease acid in the esophagus or esophagitis inflammation of the esophagus Patients with this condition have a higher risk of developing a type of cancer of the esophagus called adenocarcinoma
Polyphenon E Poly E defined green tea catechin extract is a low-caffeinated polyphenol mixture that is made from green tea Poly E contains a chemical called Epigallocatechin-3 EGCG and other chemicals called catechins Research has shown that green tea Poly E and EGCG may be effective in preventing cancer Poly E as used in this study does not contain green tea but is made from products of green tea
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study These procedures are part of regular care for someone at increased risk of esophagus cancer If you have had some of them recently they may not need to be repeated This will be up to your study doctor You will have a complete physical exam and your medical history will be reviewed You will also have routine blood tests about 2-3 tablespoons as well as an electrocardiogram ECG--a test to measure the electrical activity of the heart
If you are eligible to take part in the study and you choose to take part you will have to complete a 1-month wash-out period The wash-out period is a period in which you must not take medications herbs vitamins or mineral supplements that contain tea compounds The wash-out is a 30-day period before the baseline endoscopy Because caffeine and tea may affect the results of this trial you will be asked to not drink any tea-containing products You will also be asked to record the amount of caffeine-containing foods and medications that you consume You will be given a list of caffeine-containing foods and medications
After the wash-out period you will need to have a complete endoscopy and biopsy of your esophagus This is part of regular care for someone at increased risk for esophagus cancer This procedure will be performed in the outpatient setting An endoscopy is an exam used by your doctor to look at your esophagus the tube that connects your mouth and stomach and stomach Your doctor will place a thin scope into your mouth and carefully move the scope down the esophagus and into the stomach During the endoscopy you will have a standard biopsy and a small area of abnormal tissue will be snipped off The sample will be sent to the lab to look at the chemical and structural make-up of the cells of the esophageal lining This test will be used to find out the extent of the Barretts Esophagus
Women who are able to have children must have a negative blood pregnancy test within 2 weeks of being assigned to a treatment group
You will then be randomly assigned as in a roll of the dice by computer into one of 4 study groups You have an equal chance of being placed in each group Neither you nor your doctor can choose the group you will be in Neither you the research staff nor your doctor will know if you are taking Poly E or placebo capsules In this study you will get either defined green tea catechin extract at 1 of 3 different doses or the placebo a harmless drug that looks like the study drug but has no medical benefit
If you are assigned to Group 1 Arm I you will begin taking 1 capsule of defined green tea catechin extract orally PO twice daily BID for the next 6 months
If you are assigned to Group 2 Arm II you will begin taking 2 capsules of defined green tea catechin extract PO BID for the next 6 months
If you are assigned to Group 3 Arm III you will begin taking 3 capsules of defined green tea catechin extract PO BID for the next 6 months
If you are assigned to Group 4 Arm IV you will begin taking 1-3 capsules of placebo PO BID for the next 6 months The numbers you take in this group will depend on the amount of EGCG you are assigned to receive Each 200 mg Poly E capsule contains 200 mg of EGCG The dosage of Poly E is based on the EGCG content The study capsules do not contain green tea
You will be asked to keep a study diary during your entire participation in this study In this diary you will record exactly when you take each dose of study drug and how much you took each time You will also be asked to record the amount of caffeine-containing foods and medications that you consume
You may continue your histamine antagonist for example Zantac or Tagamet or proton pump inhibitor for example Nexium or Prilosec for any symptoms you may have
Certain tests and procedures will be performed during the study to see how the treatment is affecting your body These tests will be done every 2 weeks for the first month then once a month until the completion of 6 months of treatment You will have 20-minute follow-up visits that will including checking for any side effects and counting and writing down how much medication you have taken You will have blood drawn about 2-3 tablespoons for routine tests and you will also have urine tests 1 sample is less than 1 tablespoon
Patients with Barretts esophagus usually have an endoscopy every 1-3 years For this study it will be performed twice at the first visit and at the 6-month visit You will have to sign a separate consent form for each endoscopy You cannot take aspirin aspirin-containing substances coumadin warfarin heparin or iron supplements for 5 days before each endoscopy
You may be taken off study if intolerable side effects occur if the study doctor believes it is in your best interest if you do not follow the study rules or if the sponsor decides to stop the study for any reason
When you have finished taking 6 months of treatment either the Poly E or the placebo you will have a follow-up endoscopy and biopsy You will have follow-up visits scheduled for 3 months and 6 months after completing treatment During these visits you will be checked for side effects blood about 2-3 tablespoons will be drawn for routine tests and you will also have urine tests 1 sample is less than 1 tablespoon performed You will be contacted by telephone monthly after completing treatment to check for side effects that you may be experiencing
This is an investigational study Poly E has been authorized for use in research only Up to 55 participants will take part in this multicenter study About 12 will be enrolled at M D Anderson
I The primary objective of this study is to demonstrate the safety ie determine the maximum tolerated dose MTD of using Polyphenon E Poly E over a six-month period in the management of patients with Barretts Esophagus BE with or without low-grade dysplasia LGD
SECONDARY OBJECTIVES
I To investigate the dose-related biologic effects and pharmacodynamic properties of Poly E in order of decreasing priority
II Determine the efficacy of Poly E in inhibiting phosphorylation of EGFR or Her-2 or akt in esophageal mucosa
III Determine the pharmacodynamic profile of Poly E constituents EGCG EGC EC in esophageal tissue during and after 6 months of therapy using HPLC and GC-MS
IV Evaluate the efficacy of Poly E in reducing or stabilizing metaplasia and dysplasia of esophageal Barretts mucosa using visual endoscopic measurements and histological analysis
V Determine the efficacy of Poly E in modulating surrogate biomarkers in esophageal mucosa - degrees of tetraploidy and aneuploidy expression of cyclin D1 COX-2 EGFR Her-2 akt and Ki-67 LOH at 9p p16 and 17p p53 apoptotic index
VI Determine the efficacy of Poly E in inhibiting methylation of p16 VII Determine the efficacy of Poly E in modulating eicosanoid levels including PGE2 and lipoxygenase profiles in esophageal mucosa
The esophagus is the tube used for swallowing that connects the mouth to the stomach Barretts esophagus is a condition in which the tissue lining of the esophagus is abnormal It develops in some people who have heartburn reflux disease acid in the esophagus or esophagitis inflammation of the esophagus Patients with this condition have a higher risk of developing a type of cancer of the esophagus called adenocarcinoma
Polyphenon E Poly E defined green tea catechin extract is a low-caffeinated polyphenol mixture that is made from green tea Poly E contains a chemical called Epigallocatechin-3 EGCG and other chemicals called catechins Research has shown that green tea Poly E and EGCG may be effective in preventing cancer Poly E as used in this study does not contain green tea but is made from products of green tea
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study These procedures are part of regular care for someone at increased risk of esophagus cancer If you have had some of them recently they may not need to be repeated This will be up to your study doctor You will have a complete physical exam and your medical history will be reviewed You will also have routine blood tests about 2-3 tablespoons as well as an electrocardiogram ECG--a test to measure the electrical activity of the heart
If you are eligible to take part in the study and you choose to take part you will have to complete a 1-month wash-out period The wash-out period is a period in which you must not take medications herbs vitamins or mineral supplements that contain tea compounds The wash-out is a 30-day period before the baseline endoscopy Because caffeine and tea may affect the results of this trial you will be asked to not drink any tea-containing products You will also be asked to record the amount of caffeine-containing foods and medications that you consume You will be given a list of caffeine-containing foods and medications
After the wash-out period you will need to have a complete endoscopy and biopsy of your esophagus This is part of regular care for someone at increased risk for esophagus cancer This procedure will be performed in the outpatient setting An endoscopy is an exam used by your doctor to look at your esophagus the tube that connects your mouth and stomach and stomach Your doctor will place a thin scope into your mouth and carefully move the scope down the esophagus and into the stomach During the endoscopy you will have a standard biopsy and a small area of abnormal tissue will be snipped off The sample will be sent to the lab to look at the chemical and structural make-up of the cells of the esophageal lining This test will be used to find out the extent of the Barretts Esophagus
Women who are able to have children must have a negative blood pregnancy test within 2 weeks of being assigned to a treatment group
You will then be randomly assigned as in a roll of the dice by computer into one of 4 study groups You have an equal chance of being placed in each group Neither you nor your doctor can choose the group you will be in Neither you the research staff nor your doctor will know if you are taking Poly E or placebo capsules In this study you will get either defined green tea catechin extract at 1 of 3 different doses or the placebo a harmless drug that looks like the study drug but has no medical benefit
If you are assigned to Group 1 Arm I you will begin taking 1 capsule of defined green tea catechin extract orally PO twice daily BID for the next 6 months
If you are assigned to Group 2 Arm II you will begin taking 2 capsules of defined green tea catechin extract PO BID for the next 6 months
If you are assigned to Group 3 Arm III you will begin taking 3 capsules of defined green tea catechin extract PO BID for the next 6 months
If you are assigned to Group 4 Arm IV you will begin taking 1-3 capsules of placebo PO BID for the next 6 months The numbers you take in this group will depend on the amount of EGCG you are assigned to receive Each 200 mg Poly E capsule contains 200 mg of EGCG The dosage of Poly E is based on the EGCG content The study capsules do not contain green tea
You will be asked to keep a study diary during your entire participation in this study In this diary you will record exactly when you take each dose of study drug and how much you took each time You will also be asked to record the amount of caffeine-containing foods and medications that you consume
You may continue your histamine antagonist for example Zantac or Tagamet or proton pump inhibitor for example Nexium or Prilosec for any symptoms you may have
Certain tests and procedures will be performed during the study to see how the treatment is affecting your body These tests will be done every 2 weeks for the first month then once a month until the completion of 6 months of treatment You will have 20-minute follow-up visits that will including checking for any side effects and counting and writing down how much medication you have taken You will have blood drawn about 2-3 tablespoons for routine tests and you will also have urine tests 1 sample is less than 1 tablespoon
Patients with Barretts esophagus usually have an endoscopy every 1-3 years For this study it will be performed twice at the first visit and at the 6-month visit You will have to sign a separate consent form for each endoscopy You cannot take aspirin aspirin-containing substances coumadin warfarin heparin or iron supplements for 5 days before each endoscopy
You may be taken off study if intolerable side effects occur if the study doctor believes it is in your best interest if you do not follow the study rules or if the sponsor decides to stop the study for any reason
When you have finished taking 6 months of treatment either the Poly E or the placebo you will have a follow-up endoscopy and biopsy You will have follow-up visits scheduled for 3 months and 6 months after completing treatment During these visits you will be checked for side effects blood about 2-3 tablespoons will be drawn for routine tests and you will also have urine tests 1 sample is less than 1 tablespoon performed You will be contacted by telephone monthly after completing treatment to check for side effects that you may be experiencing
This is an investigational study Poly E has been authorized for use in research only Up to 55 participants will take part in this multicenter study About 12 will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| P30CA013696 | NIH | DCP | httpsreporternihgovquickSearchP30CA013696 |
| NCI-2009-00855 | REGISTRY | None | None |
| CDR0000653460 | None | None | None |
| CDR0000429486 | None | None | None |
| IRB-AAAB0407 | None | None | None |
| 2004-0907 | OTHER | None | None |
| MDA03-1-01 | OTHER | None | None |
| N01CN35159 | NIH | None | None |