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Erlotinib Prevention of Oral Cancer (EPOC)

NCT00402779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2020-04-21

Study results available
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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.

Conditions

  • Oral Cancer

Interventions

DRUG

Erlotinib

150 mg by mouth daily

DRUG

Placebo

Tablet by mouth daily

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Astellas Pharma US, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Vassiliki Papadimitrakopoulou, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-03
Primary Completion
2018-06-04
Completion
2018-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00402779 on ClinicalTrials.gov