Oral CancerPhase 3NCT00402779
Erlotinib Prevention of Oral Cancer (EPOC)
A Phase 3 study testing Erlotinib in people with Oral Cancer, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial summary
The goal of this clinical research study is to learn if erlotinib hydrochloride (Tarcevaâ (OSI-774 ) can prevent cancer in the mouth of people with a high risk of developing cancer in the mouth. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Nov 2006to 4 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients with one of the following: (a) loss of heterozygosity (LOH) at 3p14 and/or 9p21 in the oral IEN of patients with a history of curatively treated oral cancer or (b) LOH at 3p14 and/or 9p21 plus at one other chromosomal region in the IEN of patients with no oral cancer history.
- Participants must have confirmed diagnosis of oral IEN lesion with LOH. (Note:The initial screening biopsy of oral IEN lesion with LOH must be obtained within 12 months of study enrollment. If initial diagnostic biopsy for LOH is > 3 months prior to study enrollment, investigators may use clinical judgment to order an additional screening biopsy to assess histopathological changes).
- Age >/= 18 years
- ECOG performance status <2
- Participants must have normal organ \& marrow function as defined below w/in 30 days of randomization:CBC w/ differential white cell count-acceptable results must include:WBC >3,000ul, hemoglobin>10 g/dl, platelet count > 125,000ul, LFTs-total bilirubin \& alkaline phosphatase, AST (SGOT) \& ALT (SPGT) all w/in <1.5xULN.Note:At the discretion of the attending physician,participants w/ Gilbert's disease may still be eligible to participate in the event the total bilirubin value is >1.5xULN. Kidney function-serum creatinine< 1.5xULN Chemistry-Sodium \& potassium all w/in normal institutional limits.
- The effects of the study agent on the developing human fetus are unknown.For this reason,WOCBP \& men must agree to use adequate contraception (hormonal or barrier method of birth control;abstinence)prior to study entry\& for the duration of active treatment.Neg.serum pregnancy test in WOCBP.Childbearing potential will be defined as women who have had menses w/in the past 12 mths,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect she is pregnant while participating in this study,she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with active cancer or any cancer within the previous two years, excluding oral and non-melanoma skin cancer.
- Patients with acute intercurrent illness or who have had surgery, radiation therapy, or chemotherapy within the preceding 4 weeks unless they have fully recovered.
- Patients with a documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants
- Women who are pregnant (confirmed by b-HCG if applicable) or breastfeeding
- Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study
- Patients who have participated in other experimental therapy studies within 3 months of enrollment to this trial
- Patients with a history of inflammatory bowel disease
- Patients with a documented history of interstitial lung disease
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
The University of Chicago
Chicago, Illinois, 60637
The Univeristy of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
The goal of this clinical research study is to learn if erlotinib hydrochloride (Tarcevaâ (OSI-774 ) can prevent cancer in the mouth of people with a high risk of developing cancer in the mouth. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body.
Read the detailed description
Erlotinib hydrochloride is designed to block the activity of an enzyme found on the surface of many tumor cells that may control tumor growth and survival. This may keep tumors from growing.
If you are found to be eligible to participate in the study, you will be randomly assigned (as in the toss of a coin) to receive either erlotinib hydrochloride or placebo. A placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor the investigators will know which treatment group you have been assigned to. However, in the event of a medical emergency, the study chair can find out which group you are in, if necessary. You can be informed which of the groups you were assigned to, after the study has ended. There is no certainty that you will have an effect from the treatment, or if you will be placed in a group with the active study drug.
While on study, you will take the study dose (either erlotinib hydrochloride or placebo) by mouth, in tablet form, once a day. Tablets should be taken in the morning 1 hour before or 2 hours after a meal, other medications, vitamins, and iron supplements, with no more than 7 ounces of water. You should take the study dose around the same time every day. Every attempt should be made to keep from vomiting the dose, for at least 30 minutes after taking it. For example, if you feel nauseated before or after taking the study dose, anti-nausea medications should be used. If you vomit after taking the study dose, the dose can be taken again only if the tablet(s) can actually be seen and counted (in other words, they have not dissolved yet). You will need to note the time you take each dose of medication throughout the study on a calendar that the study nurse will give to you.
At Months 1, 3, 6, 9, and 12, you will return to clinic. You will have a physical exam including measurement of vital signs. You will have a careful examination of the inside of your mouth.You will have blood (about 2 teaspoons) drawn for routine tests and to check your liver function (about 1-2 teaspoons). At Months 3, 6, and 12, you will have blood (about 2 teaspoons) drawn for research testing and to measure the level of study drug in the body.
Your study doctor will ask you about any medications you are taking, how you are feeling (symptoms), and your current smoking and alcohol usage.
The nurse or study coordinator will collect the medication you did not take, as well as your completed pill diaries, at every clinic visit. At Months 1, 3, 6, and 9, you will also be given new study medication and pill diaries.
You may also have another small biopsy performed from the inside of your mouth in the area where the cells that might become cancerous are located. The biopsy will be performed by your doctor and will be sent to a lab for testing. At months 3 and 12, the doctor will also count and measure any red or white patches on the inside of your mouth. Biopsies will be taken after 3 months of treatment and at the end of 12 months of treatment. The tissue will be tested to see if there are any cells that might become cancerous.
Following the end of treatment, you will return to the clinic every 6 months for 2 years. You will have a complete physical exam, including measurement of vital signs. You will have a careful examination of the inside of your mouth. You will have blood drawn (about 2 teaspoons) for routine tests, to check your liver function, and for research testing. Your study doctor will ask you about any medications you are taking and how you are feeling (symptoms), and your current tobacco and alcohol use.
In addition, at the final clinic visit, you will also take part in a personal interview. During the interview, you will be asked questions regarding socio-demographic information (such as age and race), nutrition habits, current and earlier tobacco use, alcohol use habits, family history of cancer, use of medications, and how you are feeling. The interview will take about 90 minutes to complete. The purpose of the interview is to collect information to learn if there is a relationship between certain factors and your risk of developing cancer of the mouth. You may be contacted in the future in order to collect more information.
You may be taken off study if you are not able to follow the doctors' instructions, serious side effects occur, or the doctor thinks it is in your best interest to leave the study. If you are taken off study for any reason, you will be asked to return to the clinic for a final clinic visit, preferably within 14 days after leaving the study.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC. Its use in this study is considered investigational. Approximately 491 patients will be screened for this study. Up to 120 will be enrolled at MD Anderson.
- Conditions
- Oral Cancer
- Being tested
- Erlotinib, Placebo
- Keywords
- Oral Cancer, Oral IEN Lesion with LOH, Loss of Heterozygosity, Intraepithelial Neoplasia, Placebo, Erlotinib, Tarceva, OSI-774
- Medical subject headings
- Mouth Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva, OSI-774
150 mg by mouth daily
PlaceboDrug
Tablet by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Balanced randomization: Erlotinib 150 mg continuous administration for 1 year. Receives: Drug: Erlotinib |
| Placebo | Placebo comparator | Balanced randomization: Placebo continuous administration for 1 year. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group.
Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study start3 Nov 2006
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Astellas Pharma US, Inc.
- Responsible party
- Sponsor
- Investigators
- Vassiliki Papadimitrakopoulou, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402779
- Sponsor's protocol ID
- 2003-0824
- Other IDs
- EPOC, P01CA106451, NCI-2009-00873
- Status last verified
- Apr 2020
- First submitted
- 20 Nov 2006
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
William WN Jr, Papadimitrakopoulou V, Lee JJ, Mao L, Cohen EE, Lin HY, Gillenwater AM, Martin JW, Lingen MW, Boyle JO, Shin DM, Vigneswaran N, Shinn N, Heymach JV, Wistuba II, Tang X, Kim ES, Saintigny P, Blair EA, Meiller T, Gutkind JS, Myers J, El-Naggar A, Lippman SM. Erlotinib and the Risk of Oral Cancer: The Erlotinib Prevention of Oral Cancer (EPOC) Randomized Clinical Trial. JAMA Oncol. 2016 Feb;2(2):209-16. doi: 10.1001/jamaoncol.2015.4364.
PubMed 26540028Scully C. Challenges in predicting which oral mucosal potentially malignant disease will progress to neoplasia. Oral Dis. 2014 Jan;20(1):1-5. doi: 10.1111/odi.12208.
PubMed 24320967
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erlotinib Prevention of Oral Cancer (EPOC)
- ClinicalTrials.gov ID
- NCT00402779
- Acronym / sponsor ID
- 2003-0824
- Conditions
- Oral Cancer
- Keywords
- Oral Cancer, Oral IEN Lesion with LOH, Loss of Heterozygosity, Intraepithelial Neoplasia, Placebo, Erlotinib, Tarceva, OSI-774
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Astellas Pharma US, Inc.
- Study start
- 3 Nov 2006 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Posted 21 Apr 2020
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 learn if erlotinib hydrochloride (Tarcevaâ (OSI-774 ) can prevent cancer in the mouth of people with a high risk of developing cancer in the mouth. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body.
Detailed description
Erlotinib hydrochloride is designed to block the activity of an enzyme found on the surface of many tumor cells that may control tumor growth and survival. This may keep tumors from growing.
If you are found to be eligible to participate in the study, you will be randomly assigned (as in the toss of a coin) to receive either erlotinib hydrochloride or placebo. A placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor the investigators will know which treatment group you have been assigned to. However, in the event of a medical emergency, the study chair can find out which group you are in, if necessary. You can be informed which of the groups you were assigned to, after the study has ended. There is no certainty that you will have an effect from the treatment, or if you will be placed in a group with the active study drug.
While on study, you will take the study dose (either erlotinib hydrochloride or placebo) by mouth, in tablet form, once a day. Tablets should be taken in the morning 1 hour before or 2 hours after a meal, other medications, vitamins, and iron supplements, with no more than 7 ounces of water. You should take the study dose around the same time every day. Every attempt should be made to keep from vomiting the dose, for at least 30 minutes after taking it. For example, if you feel nauseated before or after taking the study dose, anti-nausea medications should be used. If you vomit after taking the study dose, the dose can be taken again only if the tablet(s) can actually be seen and counted (in other words, they have not dissolved yet). You will need to note the time you take each dose of medication throughout the study on a calendar that the study nurse will give to you.
At Months 1, 3, 6, 9, and 12, you will return to clinic. You will have a physical exam including measurement of vital signs. You will have a careful examination of the inside of your mouth.You will have blood (about 2 teaspoons) drawn for routine tests and to check your liver function (about 1-2 teaspoons). At Months 3, 6, and 12, you will have blood (about 2 teaspoons) drawn for research testing and to measure the level of study drug in the body.
Your study doctor will ask you about any medications you are taking, how you are feeling (symptoms), and your current smoking and alcohol usage.
The nurse or study coordinator will collect the medication you did not take, as well as your completed pill diaries, at every clinic visit. At Months 1, 3, 6, and 9, you will also be given new study medication and pill diaries.
You may also have another small biopsy performed from the inside of your mouth in the area where the cells that might become cancerous are located. The biopsy will be performed by your doctor and will be sent to a lab for testing. At months 3 and 12, the doctor will also count and measure any red or white patches on the inside of your mouth. Biopsies will be taken after 3 months of treatment and at the end of 12 months of treatment. The tissue will be tested to see if there are any cells that might become cancerous.
Following the end of treatment, you will return to the clinic every 6 months for 2 years. You will have a complete physical exam, including measurement of vital signs. You will have a careful examination of the inside of your mouth. You will have blood drawn (about 2 teaspoons) for routine tests, to check your liver function, and for research testing. Your study doctor will ask you about any medications you are taking and how you are feeling (symptoms), and your current tobacco and alcohol use.
In addition, at the final clinic visit, you will also take part in a personal interview. During the interview, you will be asked questions regarding socio-demographic information (such as age and race), nutrition habits, current and earlier tobacco use, alcohol use habits, family history of cancer, use of medications, and how you are feeling. The interview will take about 90 minutes to complete. The purpose of the interview is to collect information to learn if there is a relationship between certain factors and your risk of developing cancer of the mouth. You may be contacted in the future in order to collect more information.
You may be taken off study if you are not able to follow the doctors' instructions, serious side effects occur, or the doctor thinks it is in your best interest to leave the study. If you are taken off study for any reason, you will be asked to return to the clinic for a final clinic visit, preferably within 14 days after leaving the study.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC. Its use in this study is considered investigational. Approximately 491 patients will be screened for this study. Up to 120 will be enrolled at MD Anderson.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: ErlotinibBalanced randomization: Erlotinib 150 mg continuous administration for 1 year. |
| Placebo | Placebo comparator | Drug: PlaceboBalanced randomization: Placebo continuous administration for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients with one of the following: (a) loss of heterozygosity (LOH) at 3p14 and/or 9p21 in the oral IEN of patients with a history of curatively treated oral cancer or (b) LOH at 3p14 and/or 9p21 plus at one other chromosomal region in the IEN of patients with no oral cancer history.
- Participants must have confirmed diagnosis of oral IEN lesion with LOH. (Note:The initial screening biopsy of oral IEN lesion with LOH must be obtained within 12 months of study enrollment. If initial diagnostic biopsy for LOH is > 3 months prior to study enrollment, investigators may use clinical judgment to order an additional screening biopsy to assess histopathological changes).
- Age >/= 18 years
- ECOG performance status <2
- Participants must have normal organ \& marrow function as defined below w/in 30 days of randomization:CBC w/ differential white cell count-acceptable results must include:WBC >3,000ul, hemoglobin>10 g/dl, platelet count > 125,000ul, LFTs-total bilirubin \& alkaline phosphatase, AST (SGOT) \& ALT (SPGT) all w/in <1.5xULN.Note:At the discretion of the attending physician,participants w/ Gilbert's disease may still be eligible to participate in the event the total bilirubin value is >1.5xULN. Kidney function-serum creatinine< 1.5xULN Chemistry-Sodium \& potassium all w/in normal institutional limits.
Key exclusion criteria (8 listed)
- Patients with active cancer or any cancer within the previous two years, excluding oral and non-melanoma skin cancer.
- Patients with acute intercurrent illness or who have had surgery, radiation therapy, or chemotherapy within the preceding 4 weeks unless they have fully recovered.
- Patients with a documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants
- Women who are pregnant (confirmed by b-HCG if applicable) or breastfeeding
- Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study
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 |
|---|---|---|
| ErlotinibAlso: Tarceva, OSI-774150 mg by mouth daily | Drug | Erlotinib |
| PlaceboTablet by mouth daily | Drug | Placebo |
Primary outcome
Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group.
Time frame: 3 years
Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26540028William WN Jr, Papadimitrakopoulou V, Lee JJ, Mao L, Cohen EE, Lin HY, Gillenwater AM, Martin JW, Lingen MW, Boyle JO, Shin DM, Vigneswaran N, Shinn N, Heymach JV, Wistuba II, Tang X, Kim ES, Saintigny P, Blair EA, Meiller T, Gutkind JS, Myers J, El-Naggar A, Lippman SM. Erlotinib and the Risk of Oral Cancer: The Erlotinib Prevention of Oral Cancer (EPOC) Randomized Clinical Trial. JAMA Oncol. 2016 Feb;2(2):209-16. doi: 10.1001/jamaoncol.2015.4364.
- Derived from this study: PubMed 24320967Scully C. Challenges in predicting which oral mucosal potentially malignant disease will progress to neoplasia. Oral Dis. 2014 Jan;20(1):1-5. doi: 10.1111/odi.12208.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Vassiliki Papadimitrakopoulou, M.D. principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erlotinib in people with Oral Cancer, run by M.D. Anderson Cancer Center at 4 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 7 inclusion and 8 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402779, which also lists 2 linked publications.
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 21 Apr 2020.