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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
OSI Pharmaceuticals
Information provided by (Responsible Party):
Eben Rosenthal, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00570232
First received: December 6, 2007
Last updated: May 4, 2015
Last verified: May 2015
  Purpose
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.

Condition Intervention Phase
Head and Neck Cancer
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment [ Time Frame: 12 - 24 months ] [ Designated as safety issue: Yes ]
    Number of participants who had the most frequently observed undesirable effects after exposure to study drug

  • Percentage of Participants With Disease Free Status at 12 Months and 24 Months [ Time Frame: 12 - 24 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Participants Demonstrating Survival at 12 Months and 24 Months. [ Time Frame: 12 - 24 months ] [ Designated as safety issue: No ]
    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


Enrollment: 31
Study Start Date: December 2007
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tarceva
All patients will be prescribed erlotinib 150mg daily
Drug: Erlotinib
150 mg per day by mouth for 12 months
Other Name: Tarceva

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570232

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Genentech, Inc.
OSI Pharmaceuticals
Investigators
Principal Investigator: Eben Rosenthal, MD University of Alabama at Birmingham
  More Information

Responsible Party: Eben Rosenthal, Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00570232     History of Changes
Other Study ID Numbers: F070824015  UAB 0718 
Study First Received: December 6, 2007
Results First Received: March 24, 2015
Last Updated: May 4, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Resectable, recurrent head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2016