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NCT Number: NCT00570232

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erlotinib

Drug

150 mg per day by mouth for 12 months

Other names: Tarceva

Primary outcomes

  1. Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment

    Time frame: 12 - 24 months

    Number of participants who had the most frequently observed undesirable effects after exposure to study drug

  2. Percentage of Participants With Disease Free Status at 12 Months and 24 Months

    Time frame: 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 outcomes

  1. Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Genentech, Inc.
  • OSI Pharmaceuticals

Registry information

Official study title

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

Acronym: UAB0718

Important dates

Study start
2007
Primary completion
2014
Study completion
2015
First posted
Dec 10, 2007
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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