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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
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: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Evaluate the safety and tolerability of long term erlotinib treatment [ Time Frame: 12 - 24 months ] [ Designated as safety issue: Yes ]
  • Determine disease free survival at 12 months and 24 months [ Time Frame: 12 - 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of subjects alive at 12 months and 24 months. [ Time Frame: 12 - 24 months ] [ Designated as safety issue: No ]
  • Duration of overall survival [ Time Frame: 12 - 24 months ] [ Designated as safety issue: No ]
  • Determine EGFR positivity, phosphorylation status and histopathological changes in the primary and recurrent disease [ Time Frame: 12 - 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: December 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tarceva
All patients will be prescribed Tarceva 150mg daily
 Drug: Erlotinib
150 mg per day by mouth for 12 months
Other Name: Tarceva

  Eligibility

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
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
OSI Pharmaceuticals
Investigators
Principal Investigator: Eben Rosenthal, MD University of Alabama at Birmingham
  More Information

No publications provided

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
Last Updated: January 15, 2013
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
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013