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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Erlotinib

• Registration Number: NCT00570232
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Results First Submitted: 2015-03-24
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-04
• Last Update Submitted: 2015-05-04
• Results First Posted: 2015-05-21
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
3. Prior radiation therapy for head and neck cancer
4. Disease must be considered surgically resectable or candidate for curative reirradiation
5. Adequate diagnostic workup
6. Zubrod Performance Status 0-2
7. Life expectancy 12 weeks
8. Age 19, 9. Adequate laboratory data.

Exclusion Criteria

1. 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)
2. Patients who are pregnant or lactating
3. Psychological condition that renders the patient unable to understand the informed consent
4. Any situation or condition that will interfere with adherence to study activities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tarceva	Erlotinib	All patients will be prescribed erlotinib 150mg daily

Primary Outcome Measures

Name	Time	Method
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment	12 - 24 months	Number of participants who had the most frequently observed undesirable effects after exposure to study drug
Percentage of Participants With Disease Free Status at 12 Months and 24 Months	12 - 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)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.	12 - 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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States