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Erlotinib Prevention of Oral Cancer (EPOC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00402779
First received: November 20, 2006
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

Objectives:

This study will test the ability of an epidermal growth factor receptor (EGFR) inhibitor (erlotinib) to reduce the incidence of oral cancer in the high-risk setting of oral leukoplakia with LOH in two cohorts, oral IEN (Intraepithelial neoplasia) patients with LOH in 3p and/or 9p and one other specific chromosomal locus but without cancer or oral IEN patients with LOH in 3p and/or 9p associated with curatively treated oral cancer. Researchers will test this treatment in a randomized clinical trial with 2 treatment arms: Erlotinib 150mg orally each day or placebo.

Primary Aim:

The primary endpoint of the trial will be the oral cancer-free survival in patients receiving erlotinib as compared with the control or placebo group.

Secondary Aims:

  1. The size, number, and appearance of oral IEN will be assessed and correlated with cancer risk. A > 50% reduction in the bidimensional measurements of IEN lesions is considered a treatment response. Researchers hypothesize that patients with IEN lesions and loss of heterozygosity (LOH) of the oral cavity will respond to erlotinib.
  2. To examine toxicity associated with erlotinib. Researchers hypothesis that patients with oral lesions will tolerate treatment with erlotinib.
  3. To assess a panel of molecular markers for correlations with oral cancer development in oral IEN patients.

Condition Intervention Phase
Oral Cancer
Drug: Erlotinib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Erlotinib Prevention of Oral Cancer (EPOC)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Oral cancer-free survival [ Time Frame: Every 3 Months ] [ Designated as safety issue: No ]
    Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer.


Estimated Enrollment: 150
Study Start Date: November 2006
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Intraepithelial neoplasia (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. Eastern Cooperative Oncology Group (ECOG) performance status <2
  5. Participants must have normal organ & marrow function as defined below within 30 days of randomization: complete blood count (CBC) with differential white cell count (WBC)-acceptable results must include: WBC >3,000ul, hemoglobin>10 g/dl, platelet count > 125,000ul, Liver Function Tests (LFTs)-total bilirubin & alkaline phosphatase, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) all within <1.5*upper limits of normal (ULN). Note:At the discretion of the attending physician,participants with Gilbert's disease may still be eligible to participate in the event the total bilirubin value is >1.5*ULN. Kidney function-serum creatinine< 1.5*ULN Chemistry-Sodium & potassium all within normal institutional limits.
  6. The effects of the study agent on the developing human fetus are unknown. For this reason, Women of Childbearing Potential (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. Negative serum pregnancy test in WOCBP. Childbearing potential will be defined as women who have had menses within the past 12 months, 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 beta human chorionic gonadotropin (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402779

Locations
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
Investigators
Principal Investigator: Vassiliki Papadimitrakopoulou, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00402779     History of Changes
Other Study ID Numbers: 2003-0824, EPOC, P01CA106451
Study First Received: November 20, 2006
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Oral Cancer
Oral IEN Lesion with LOH
Loss of Heterozygosity
Intraepithelial Neoplasia
Placebo
Erlotinib
Tarceva
OSI-774

Additional relevant MeSH terms:
Lip Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Lip Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014