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Erlotinib Prevention of Oral Cancer (EPOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00402779
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Oral Cancer Drug: Erlotinib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Erlotinib Prevention of Oral Cancer (EPOC)
Actual Study Start Date : November 3, 2006
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 4, 2018

Arm Intervention/treatment
Experimental: Erlotinib
Balanced randomization: Erlotinib 150 mg continuous administration for 1 year.
Drug: Erlotinib
150 mg by mouth daily
Other Names:
  • Tarceva
  • OSI-774

Placebo Comparator: Placebo
Balanced randomization: Placebo continuous administration for 1 year.
Drug: Placebo
Tablet by mouth daily

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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).
  3. Age >/= 18 years
  4. ECOG performance status <2
  5. 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.
  6. 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
  7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Patients with active cancer or any cancer within the previous two years, excluding oral and non-melanoma skin cancer.
  2. Patients with acute intercurrent illness or who have had surgery, radiation therapy, or chemotherapy within the preceding 4 weeks unless they have fully recovered.
  3. Patients with a documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants
  4. Women who are pregnant (confirmed by b-HCG if applicable) or breastfeeding
  5. Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study
  6. Patients who have participated in other experimental therapy studies within 3 months of enrollment to this trial
  7. Patients with a history of inflammatory bowel disease
  8. Patients with a documented history of interstitial lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402779

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United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
The Univeristy of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
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Principal Investigator: Vassiliki Papadimitrakopoulou, M.D. M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00402779    
Other Study ID Numbers: 2003-0824
P01CA106451 ( U.S. NIH Grant/Contract )
NCI-2009-00873 ( Registry Identifier: NCI CTRP )
First Posted: November 22, 2006    Key Record Dates
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Oral Cancer
Oral IEN Lesion with LOH
Loss of Heterozygosity
Intraepithelial Neoplasia
Additional relevant MeSH terms:
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Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action