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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring Resectable, recurrent head and neck cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tarceva

Arm Description

All patients will be prescribed erlotinib 150mg daily

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
December 6, 2007
Last Updated
May 4, 2015
Sponsor
University of Alabama at Birmingham
Collaborators
Genentech, Inc., OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00570232
Brief Title
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Acronym
UAB0718
Official Title
Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Genentech, Inc., OSI Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Resectable, recurrent head and neck cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tarceva
Arm Type
Other
Arm Description
All patients will be prescribed erlotinib 150mg daily
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
150 mg per day by mouth for 12 months
Primary Outcome Measure Information:
Title
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
Description
Number of participants who had the most frequently observed undesirable effects after exposure to study drug
Time Frame
12 - 24 months
Title
Percentage of Participants With Disease Free Status at 12 Months and 24 Months
Description
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)
Time Frame
12 - 24 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
Description
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
Time Frame
12 - 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eben Rosenthal, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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