Clinical Trial: Erlotinib Prevention of Oral Cancer (EPOC)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Erlotinib Prevention of Oral Cancer (EPOC)

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.

Detailed Summary:

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 ret
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Oral cancer-free survival [ Time Frame: 3 Months ]

Original Primary Outcome: This study will test the ability of an 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) pts.

Current Secondary Outcome:

Original Secondary Outcome: To evaluate the size, number, and appearance of oral IEN will be assessed and correlated with cancer risk. To assess a panel of molecular markers for correlations with oral cancer development in our oral IEN patients.

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: November 20, 2006
Date Started: November 2006
Date Completion:
Last Updated: September 22, 2016
Last Verified: September 2016