Barrett EsophagusPhase 1NCT00233935
Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus
A Phase 1 study testing defined green tea catechin extract in people with Barrett Esophagus, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- defined green tea catechin extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2005to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed diagnosis of Barrett's metaplasia within 12 months prior to trial entry
- Note: The presence of LGD may be subject to disagreement between pathologists; this will not affect trial entry, since patients with or without LGD are eligible to participate; all cases in which there is disagreement regarding the presence of LGD will be reviewed by a third pathologist for histological classification prior to the efficacy analysis
- Cases of short-segment (less than or equal to 3 cm) Barrett's esophagus must be large enough to allow adequate sampling of tissue without completely resecting the metaplasia
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
- Leukocytes greater than or equal to 3,000/UL
- Absolute neutrophil count greater than or equal to 1,500/UL
Show all 23Show fewer
- Platelets greater than or equal to 100,000/UL
- Total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) less than or equal to institutional ULN
- Creatinine within normal institutional limits
- Alkaline phosphatase less than or equal to the institutional ULN
- Willingness to abstain from all tea consumption while on the study drug
- Willingness to record intake of caffeine-containing foods and medications while on the study
- A significant portion of caffeine intake occurs from "hidden" sources, including medications and foods
- Study subjects will be provided a list of permissible medications, beverages and foods which contain caffeine
- Participants may continue therapy with proton pump inhibitors, nonsteroidal anti-inflammatory agents, and celecoxib or rofecoxib
- Pregnancy testing to within 2 weeks prior to randomization
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- If a female participant does become pregnant while on study, she will be removed from the study
- Willingness to comply with all treatment and follow-up procedures
- Willingness to wait at least one month since last endoscopic evaluation
- Ability to understand and willingness to sign a written informed consent document
- Inclusion of women and minorities: both men and women and members of all races and ethnic groups are eligible for this trial
Who cannot join
- Histologically confirmed high-grade dysplasia
- Histologically confirmed diagnosis of invasive carcinoma of the esophagus
- Prior endoscopic therapy for Barrett's esophagus, including mucosal ablation, resection and esophagectomy, and photodynamic therapy
- History of esophageal strictures with moderate-to-severe dysphagia or odynophagia that may interfere with ingestion/swallowing of the study drug
- Trial participation will be determined by the study investigator after consideration of other factors including severity of dysphagia and odynophagia, necessity for treatment of strictures, and nutritional status
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Poly E
Show all 13Show fewer
- Participants may not be receiving any other investigational agents within 30 days prior to randomization or during the study
- Use of medications, herbs, and vitamin and mineral supplements that contain tea compounds should not be taken while participating in the study and on study drug and for 30 days prior to trial entry
- If patients are consuming any of these items and would like to participate in this study, then a 30-day voluntary washout will be required
- Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;
- Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, stage Ia grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiation; or psychiatric illness/social situations that would limit compliance with study requirements
- Participants will not take aspirin, aspirin-containing substances, Coumadin (warfarin), heparin, or iron for 5 days before each endoscopy
- Active gastrointestinal bleeding; predisposing condition to gastrointestinal bleeding (including but not limited to gastritis, diverticulitis, colitis, and hemorrhoids); active malignancy diagnosed or treated within 5 years, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ
Trial locations and contacts
3 sites in 1 country.
United States3 sites
M D Anderson Cancer Center
Houston, Texas, 77030
Columbia University Medical Center
New York, New York, 10032
Weill Medical College of Cornell University
New York, New York, 10065
About this study
Official title: Phase Ib Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients With Barrett's Esophagus
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 Barrett's 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.
Read the detailed description
PRIMARY OBJECTIVES:
- The primary objective of this study is to demonstrate the safety (i.e., determine the maximum tolerated dose (MTD)) of using Polyphenon E (Poly E) over a six-month period in the management of patients with Barrett's Esophagus (BE) with or without low-grade dysplasia (LGD).
SECONDARY OBJECTIVES:
- 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 Barrett's mucosa using visual endoscopic measurements and histological analysis.
- 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. Barrett's 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 Barrett's 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 Barrett's 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.
- Conditions
- Barrett Esophagus
- Being tested
- placebo, defined green tea catechin extract
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Also called PLCB
Given PO
defined green tea catechin extractDrug
Also called Polyphenon E
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (1 capsule) | Experimental | Patients receive 1 capsule of defined green tea catechin extract PO BID for the next 6 months. Receives: Drug: defined green tea catechin extract |
| Arm II (2 capsules) | Experimental | Patients receive 2 capsules of defined green tea catechin extract PO BID for the next 6 months. Receives: Drug: defined green tea catechin extract |
| Arm III (3 capsules) | Experimental | Patients receive 3 capsules of defined green tea catechin extract PO BID for the next 6 months. Receives: Drug: defined green tea catechin extract |
| Arm IV (placebo) | Placebo comparator | Patients receive 1-3 capsules of placebo PO BID for the next 6 months. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity defined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (Version 3.0)
Measured: Up to 6 months
Secondary outcomes (1)
Dose-related biologic effects and pharmacodynamic properties of Poly E
Generalized linear models will be used.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles Lightdale, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233935
- Sponsor's protocol ID
- NCI-2009-00855
- Other IDs
- NCI-2009-00855, CDR0000653460, CDR0000429486, IRB-AAAB0407, 2004-0907, MDA03-1-01, N01CN35159, P30CA013696
- Status last verified
- Apr 2013
- First submitted
- 5 Oct 2005
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients With Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT00233935
- Acronym / sponsor ID
- NCI-2009-00855
- Conditions
- Barrett Esophagus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Barrett's 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:
- The primary objective of this study is to demonstrate the safety (i.e., determine the maximum tolerated dose (MTD)) of using Polyphenon E (Poly E) over a six-month period in the management of patients with Barrett's Esophagus (BE) with or without low-grade dysplasia (LGD).
SECONDARY OBJECTIVES:
- 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 Barrett's mucosa using visual endoscopic measurements and histological analysis.
- 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. Barrett's 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 Barrett's 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 Barrett's 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (1 capsule) | Experimental | Drug: defined green tea catechin extractPatients receive 1 capsule of defined green tea catechin extract PO BID for the next 6 months. |
| Arm II (2 capsules) | Experimental | Drug: defined green tea catechin extractPatients receive 2 capsules of defined green tea catechin extract PO BID for the next 6 months. |
| Arm III (3 capsules) | Experimental | Drug: defined green tea catechin extractPatients receive 3 capsules of defined green tea catechin extract PO BID for the next 6 months. |
| Arm IV (placebo) | Placebo comparator | Other: placeboPatients receive 1-3 capsules of placebo PO BID for the next 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically-confirmed diagnosis of Barrett's metaplasia within 12 months prior to trial entry
- Note: The presence of LGD may be subject to disagreement between pathologists; this will not affect trial entry, since patients with or without LGD are eligible to participate; all cases in which there is disagreement regarding the presence of LGD will be reviewed by a third pathologist for histological classification prior to the efficacy analysis
- Cases of short-segment (less than or equal to 3 cm) Barrett's esophagus must be large enough to allow adequate sampling of tissue without completely resecting the metaplasia
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
- Leukocytes greater than or equal to 3,000/UL
Key exclusion criteria (13 listed)
- Histologically confirmed high-grade dysplasia
- Histologically confirmed diagnosis of invasive carcinoma of the esophagus
- Prior endoscopic therapy for Barrett's esophagus, including mucosal ablation, resection and esophagectomy, and photodynamic therapy
- History of esophageal strictures with moderate-to-severe dysphagia or odynophagia that may interfere with ingestion/swallowing of the study drug
- Trial participation will be determined by the study investigator after consideration of other factors including severity of dysphagia and odynophagia, necessity for treatment of strictures, and nutritional status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: PLCBGiven PO | Other | Arm IV (placebo) |
| defined green tea catechin extractAlso: Polyphenon EGiven PO | Drug | Arm I (1 capsule), Arm II (2 capsules), Arm III (3 capsules) |
Primary outcome
Toxicity defined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (Version 3.0)
Time frame: Up to 6 months
1 secondary outcome
Dose-related biologic effects and pharmacodynamic properties of Poly E
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Lightdale principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing defined green tea catechin extract in people with Barrett Esophagus, run by National Cancer Institute (NCI) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity defined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (Version 3.0) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.