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

NCT ID: NCT00570232

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tarceva

All patients will be prescribed erlotinib 150mg daily

Group Type: OTHER

Erlotinib

Intervention Type: DRUG

150 mg per day by mouth for 12 months

Interventions

Erlotinib

150 mg per day by mouth for 12 months

Intervention Type: DRUG

Other Intervention Names

Tarceva

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Eben Rosenthal

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eben Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB 0718

Identifier Type: OTHER

Identifier Source: secondary_id

F070824015

Identifier Type: -

Identifier Source: org_study_id