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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

December 6, 2007
January 15, 2013
December 2007
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00570232 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
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 radiation. This study will also determine what effects, good and/or bad, this drug has.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Head and Neck Cancer
Drug: Erlotinib
150 mg per day by mouth for 12 months
Other Name: Tarceva
Tarceva
All patients will be prescribed Tarceva 150mg daily
Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
December 2015
December 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00570232
F070824015, UAB 0718
Yes
Eben Rosenthal, University of Alabama at Birmingham
University of Alabama at Birmingham
  • Genentech
  • OSI Pharmaceuticals
Principal Investigator: Eben Rosenthal, MD University of Alabama at Birmingham
University of Alabama at Birmingham
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP