NCT00402779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

11.6 years

First QC Date

November 20, 2006

Results QC Date

February 17, 2020

Last Update Submit

April 13, 2020

Conditions

Oral Cancer

Keywords

Oral CancerOral IEN Lesion with LOHLoss of HeterozygosityIntraepithelial NeoplasiaPlaceboErlotinibTarcevaOSI-774

Outcome Measures

Primary Outcomes (1)

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

    Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer.

    3 years

Study Arms (2)

Erlotinib

EXPERIMENTAL

Balanced randomization: Erlotinib 150 mg continuous administration for 1 year.

Drug: Erlotinib

Placebo

PLACEBO COMPARATOR

Balanced randomization: Placebo continuous administration for 1 year.

Drug: Placebo

Interventions

ErlotinibDRUG

150 mg by mouth daily

Also known as: Tarceva, OSI-774
Erlotinib
PlaceboDRUG

Tablet by mouth daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with active cancer or any cancer within the previous two years, excluding oral and non-melanoma skin cancer.
  • Patients with acute intercurrent illness or who have had surgery, radiation therapy, or chemotherapy within the preceding 4 weeks unless they have fully recovered.
  • Patients with a documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants
  • Women who are pregnant (confirmed by b-HCG if applicable) or breastfeeding
  • Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study
  • Patients who have participated in other experimental therapy studies within 3 months of enrollment to this trial
  • Patients with a history of inflammatory bowel disease
  • Patients with a documented history of interstitial lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

The Univeristy of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • William WN Jr, Papadimitrakopoulou V, Lee JJ, Mao L, Cohen EE, Lin HY, Gillenwater AM, Martin JW, Lingen MW, Boyle JO, Shin DM, Vigneswaran N, Shinn N, Heymach JV, Wistuba II, Tang X, Kim ES, Saintigny P, Blair EA, Meiller T, Gutkind JS, Myers J, El-Naggar A, Lippman SM. Erlotinib and the Risk of Oral Cancer: The Erlotinib Prevention of Oral Cancer (EPOC) Randomized Clinical Trial. JAMA Oncol. 2016 Feb;2(2):209-16. doi: 10.1001/jamaoncol.2015.4364.

    PMID: 26540028DERIVED

  • Scully C. Challenges in predicting which oral mucosal potentially malignant disease will progress to neoplasia. Oral Dis. 2014 Jan;20(1):1-5. doi: 10.1111/odi.12208.

    PMID: 24320967DERIVED

Related Links

MeSH Terms

Conditions

Mouth NeoplasmsCarcinoma in Situ

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. John V. Heymach, PHD/Chair, Thoracic-Head & Neck Med Onc
Organization
UT MD Anderson Cancer Center
jheymach@mdanderson.org
713-792-6363

Study Officials

  • Vassiliki Papadimitrakopoulou, M.D.

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

November 3, 2006

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

April 21, 2020

Results First Posted

April 21, 2020

Record last verified: 2020-04

Locations

US(4)