Erlotinib Prevention of Oral Cancer (EPOC)
Condition: Oral Cancer
MeSH terms: Mouth Neoplasms; Lip Neoplasms
Intervention: Erlotinib; Placebo
Intervention description: 150 mg by mouth daily; Tablet by mouth daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral Cancer; Oral IEN Lesion with LOH; Loss of Heterozygosity; Intraepithelial Neoplasia; Placebo; Erlotinib; Tarceva; OSI-774

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.
    

Eligibility 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 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