Erlotinib Prevention of Oral Cancer (EPOC)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00402779
Phase
PHASE3
Status
Completed

Conditions

  • Oral Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    150 mg by mouth daily
  • Placebo — DRUG
    Tablet by mouth daily

Study Details

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.

Key Dates

Start date
Nov 3, 2006
Status verified
Apr 2020
Primary completion
Jun 4, 2018
Completion
Jun 4, 2018

Study Design

Enrollment
303 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Erlotinib
    Balanced randomization: Erlotinib 150 mg continuous administration for 1 year.
  • Placebo Comparator: Placebo
    Balanced randomization: Placebo continuous administration for 1 year.

Primary Outcome Measure

Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group. [ Time Frame: 3 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
The University of ChicagoChicagoIllinois60637-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
The Univeristy of Texas M. D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Atlanta, GA

By research site
Emory University Winship Cancer Institute· Atlanta, GAThe University of Chicago· Chicago, ILMemorial Sloan Kettering Cancer Center· New York, NYThe Univeristy of Texas M. D. Anderson Cancer Center· Houston, TX

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