UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer (UAB0718)

May 4, 2015 updated by: Eben Rosenthal, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tarceva
All patients will be prescribed erlotinib 150mg daily
Drug: Erlotinib
150 mg per day by mouth for 12 months
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 - 24 months
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)
12 - 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 - 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Genentech, Inc.
OSI Pharmaceuticals

Investigators

  • Principal Investigator: Eben Rosenthal, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 10, 2007

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F070824015
  • UAB 0718 (Other Identifier: UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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