CompletedPhase 3

Erlotinib Prevention of Oral Cancer (EPOC)

United States303 participantsStarted 2006-11-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

What they're measuring

Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group.

Timeframe: 3 years

Trial details

NCT IDNCT00402779

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-04

Results submitted2020-02-17

View on ClinicalTrials.gov More Oral Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Erlotinib Prevention of Oral Cancer (EPOC)

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Erlotinib Prevention of Oral Cancer (EPOC)

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria