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Erlotinib Prevention of Oral Cancer (EPOC)

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ClinicalTrials.gov Identifier: NCT00402779
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Oral Cancer
Interventions Drug: Erlotinib
Drug: Placebo
Enrollment 303
Recruitment Details Patients seen at the following sites exhibiting oral leukoplakia we approached and enrolled if interested. These include MD Anderson Cancer Center, Memorial Sloan-Kettering, Emory University,the University of Chicago, and the University of Maryland.
Pre-assignment Details Patients with leukoplakia were screened and, once eligibility was confirmed, patients willing to proceed were randomized to erlotinib or placebo in a double-blinded manner.
Arm/Group Title Erlotinib Placebo
Hide Arm/Group Description Erlotinib 150 mg PO daily x 12 months Placebo PO daily x 12 months
Period Title: Overall Study
Started 152 151
Completed 75 75
Not Completed 77 76
Reason Not Completed
Screen Failure             77             76
Arm/Group Title Erlotinib Placebo Total
Hide Arm/Group Description Erlotinib 150 mg PO daily x 12 months Placebo PO daily x 12 months Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
21-30 years
3
   4.0%
2
   2.7%
5
   3.3%
31-40 years
6
   8.0%
9
  12.0%
15
  10.0%
41-50 years
14
  18.7%
13
  17.3%
27
  18.0%
51-60 years
21
  28.0%
25
  33.3%
46
  30.7%
61-70 years
20
  26.7%
22
  29.3%
42
  28.0%
71-80 years
10
  13.3%
4
   5.3%
14
   9.3%
81-90 years
1
   1.3%
0
   0.0%
1
   0.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
32
  42.7%
33
  44.0%
65
  43.3%
Male
43
  57.3%
42
  56.0%
85
  56.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Hispanic or Latino
5
   6.7%
5
   6.7%
10
   6.7%
Not Hispanic or Latino
70
  93.3%
70
  93.3%
140
  93.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.7%
0
   0.0%
2
   1.3%
Native Hawaiian or Other Pacific Islander
1
   1.3%
0
   0.0%
1
   0.7%
Black or African American
1
   1.3%
2
   2.7%
3
   2.0%
White
68
  90.7%
67
  89.3%
135
  90.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   4.0%
6
   8.0%
9
   6.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
United States 73 75 148
Europe 2 0 2
1.Primary Outcome
Title Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group.
Hide Description Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib Placebo
Hide Arm/Group Description:
Erlotinib 150 mg PO daily x 12 months
Placebo PO daily x 12 months
Overall Number of Participants Analyzed 75 75
Measure Type: Count of Participants
Unit of Measure: Participants
55
  73.3%
18
  24.0%
Time Frame From drug start through 30 days after drug discontinuation, an average of 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib Placebo
Hide Arm/Group Description Erlotinib 150 mg PO daily x 12 months Placebo PO daily x 12 months
All-Cause Mortality
Erlotinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/75 (8.00%)   6/75 (8.00%) 
Hide Serious Adverse Events
Erlotinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/75 (13.33%)   4/75 (5.33%) 
Cardiac disorders     
Cardiac ischemia/infarction  1  0/75 (0.00%)  1/75 (1.33%) 
Gastrointestinal disorders     
Dehydration  1  1/75 (1.33%)  0/75 (0.00%) 
Infections and infestations     
Infection  1  1/75 (1.33%)  2/75 (2.67%) 
Pneumonia  1  0/75 (0.00%)  1/75 (1.33%) 
Musculoskeletal and connective tissue disorders     
Pain  1  2/75 (2.67%)  0/75 (0.00%) 
Nervous system disorders     
Speech Impairment  1  1/75 (1.33%)  0/75 (0.00%) 
Confusion  1  1/75 (1.33%)  0/75 (0.00%) 
Dizzines  1  1/75 (1.33%)  0/75 (0.00%) 
Blurred Vision  1  1/75 (1.33%)  0/75 (0.00%) 
Reproductive system and breast disorders     
Altered Sexual Function  1  1/75 (1.33%)  0/75 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash Acneiform  1  1/75 (1.33%)  0/75 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   68/75 (90.67%)   32/75 (42.67%) 
Blood and lymphatic system disorders     
Anemia  1  14/75 (18.67%)  20/75 (26.67%) 
Decreased Leukocytes  1  10/75 (13.33%)  0/75 (0.00%) 
Cardiac disorders     
Dizziness  1  9/75 (12.00%)  4/75 (5.33%) 
Hypertension  1  0/75 (0.00%)  6/75 (8.00%) 
Eye disorders     
Dry Eye  1  0/75 (0.00%)  6/75 (8.00%) 
Gastrointestinal disorders     
Weight loss  1  5/75 (6.67%)  0/75 (0.00%) 
Diarrhea  1  68/75 (90.67%)  18/75 (24.00%) 
Distension  1  5/75 (6.67%)  0/75 (0.00%) 
Dry mouth  1  9/75 (12.00%)  0/75 (0.00%) 
Dysphagia  1  4/75 (5.33%)  0/75 (0.00%) 
Flatulance  1  5/75 (6.67%)  0/75 (0.00%) 
Dyspepsia  1  14/75 (18.67%)  6/75 (8.00%) 
Mucositis  1  15/75 (20.00%)  7/75 (9.33%) 
Epistaxis  1  4/75 (5.33%)  0/75 (0.00%) 
Rectal bleeding  1  4/75 (5.33%)  0/75 (0.00%) 
Pain  1  25/75 (33.33%)  24/75 (32.00%) 
Nausea  1  0/75 (0.00%)  12/75 (16.00%) 
General disorders     
Fatigue  1  46/75 (61.33%)  21/75 (28.00%) 
Fever  1  9/75 (12.00%)  0/75 (0.00%) 
Insomnia  1  9/75 (12.00%)  0/75 (0.00%) 
Edema/head and neck  1  4/75 (5.33%)  0/75 (0.00%) 
Headache  1  0/75 (0.00%)  15/75 (20.00%) 
Infections and infestations     
Sinus Infection  1  0/75 (0.00%)  4/75 (5.33%) 
Investigations     
Elevated Alk Phos  1  6/75 (8.00%)  0/75 (0.00%) 
Elevated ALT  1  10/75 (13.33%)  13/75 (17.33%) 
Elevated Creatinine  1  9/75 (12.00%)  7/75 (9.33%) 
Elevated bilirubin  1  16/75 (21.33%)  18/75 (24.00%) 
Elevated AST  1  24/75 (32.00%)  0/75 (0.00%) 
Hyperkalemia  1  11/75 (14.67%)  1/75 (1.33%) 
Hypomagnesemia  1  17/75 (22.67%)  0/75 (0.00%) 
Hyponatremia  1  6/75 (8.00%)  0/75 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain  1  6/75 (8.00%)  5/75 (6.67%) 
Psychiatric disorders     
Depression  1  7/75 (9.33%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  14/75 (18.67%)  0/75 (0.00%) 
Dyspnea  1  4/75 (5.33%)  0/75 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  14/75 (18.67%)  0/75 (0.00%) 
Derm Other  1  12/75 (16.00%)  0/75 (0.00%) 
Dry skin  1  30/75 (40.00%)  13/75 (17.33%) 
Pruritis  1  49/75 (65.33%)  15/75 (20.00%) 
Rash  1  38/75 (50.67%)  19/75 (25.33%) 
Rash-acneiform  1  65/75 (86.67%)  12/75 (16.00%) 
Pain  1  19/75 (25.33%)  0/75 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John V. Heymach, PHD/Chair, Thoracic-Head & Neck Med Onc
Organization: UT MD Anderson Cancer Center
Phone: 713-792-6363
EMail: jheymach@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00402779    
Other Study ID Numbers: 2003-0824
EPOC
P01CA106451 ( U.S. NIH Grant/Contract )
NCI-2009-00873 ( Registry Identifier: NCI CTRP )
First Submitted: November 20, 2006
First Posted: November 22, 2006
Results First Submitted: February 17, 2020
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020