UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed Prior radiation therapy for head and neck cancer Disease must be considered surgically resectable or candidate for curative reirradiation Adequate diagnostic workup Zubrod Performance Status 0-2 Life expectancy 12 weeks Age 19, 9. Adequate laboratory data. Exclusion Criteria: Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible) Patients who are pregnant or lactating Psychological condition that renders the patient unable to understand the informed consent Any situation or condition that will interfere with adherence to study activities.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tarceva<br>All patients will be prescribed erlotinib 150mg daily | Drug: Erlotinib<br>* 150 mg per day by mouth for 12 months<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 12 - 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 - 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resectable, recurrent head and neck cancer