Phase 2 N=31 Prevention

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

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00570232 ↗

Enrolled (actual)

Serious AEs

29.0%

Results posted

May 2015

Primary outcome: Primary: Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment — 26; 22; 22; 6 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Erlotinib (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment	26; 22; 22; 6; 6; 4	—
PRIMARY Percentage of Participants With Disease Free Status at 12 Months and 24 Months	54; 45	—
SECONDARY Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.	61; 56	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00570232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.