This trial is active, not recruiting.

Condition head and neck cancer
Treatment erlotinib
Phase phase 2
Target EGFR
Sponsor University of Alabama at Birmingham
Collaborator Genentech
Start date December 2007
End date April 2014
Trial size 32 participants
Trial identifier NCT00570232, F070824015, UAB 0718


The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with radiation. This study will also determine what effects, good and/or bad, this drug has.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
All patients will be prescribed Tarceva 150mg daily
erlotinib Tarceva
150 mg per day by mouth for 12 months

Primary Outcomes

Evaluate the safety and tolerability of long term erlotinib treatment
time frame: 12 - 24 months
Determine disease free survival at 12 months and 24 months
time frame: 12 - 24 months

Secondary Outcomes

Percent of subjects alive at 12 months and 24 months.
time frame: 12 - 24 months
Duration of overall survival
time frame: 12 - 24 months
Determine EGFR positivity, phosphorylation status and histopathological changes in the primary and recurrent disease
time frame: 12 - 24 months

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Principal investigator Eben Rosenthal, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.