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

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00570232

Run by

University of Alabama at Birmingham

People needed

31

Starts

2007-12-01

Expected to finish

2015-03-01

Last updated by the study team

2015-05-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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