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

NCT00570232 | Completed Phase 2 Results DMC

• 2 other identifiers: F070824015UAB 0718
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Resectable, recurrent head and neck cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.

  12 - 24 months

Study Arms (1)

Tarceva

OTHER

All patients will be prescribed erlotinib 150mg daily

Drug: Erlotinib

Interventions

Erlotinib DRUG

150 mg per day by mouth for 12 months

Also known as: Tarceva

Tarceva

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Genentech, Inc.: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eben Rosenthal,MD
• Organization: University of Alabama at Birmingham

erosenthal@uabmc.edu

2059349713

Study Officials

• Eben Rosenthal, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 21, 2015
• Results First Posted: May 21, 2015

Record last verified: 2015-05

Locations

US (1)