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

Head and Neck Cancer Clinical Trial

— UAB0718  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570232
• Other study ID #: F070824015
• Secondary ID: UAB 0718
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2007
• Last updated: May 4, 2015
• Start date: December 2007
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Erlotinib
150 mg per day by mouth for 12 months

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Genentech, Inc., OSI Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 - 24 months	Yes
Primary	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)	12 - 24 months	No
Secondary	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	12 - 24 months	No