The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.
An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
31
150 mg per day by mouth for 12 months
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
Number of participants who had the most frequently observed undesirable effects after exposure to study drug
Time frame: 12 - 24 months
Percentage of Participants With Disease Free Status at 12 Months and 24 Months
Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)
Time frame: 12 - 24 months
Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy
Time frame: 12 - 24 months
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