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


Phase 2
N/A
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the safety and tolerability of long term erlotinib treatment

Outcome Time Frame:

12 - 24 months

Safety Issue:

Yes

Principal Investigator

Eben Rosenthal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

F070824015

NCT ID:

NCT00570232

Start Date:

December 2007

Completion Date:

December 2015

Related Keywords:

  • Head and Neck Cancer
  • Resectable, recurrent head and neck cancer
  • Head and Neck Neoplasms

Name

Location
University of Alabama at Birmingham Birmingham, Alabama  35294-3300