UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | December 2007 |
| End Date: | December 2013 |
| Contact: | Lisa K Clemons, MSN |
| Email: | lclemons@uab.edu |
| Phone: | (205) 934-9714 |
Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
The purpose of this study is to determine whether erlotinib will be effective in controlling
cancer that has returned after treatment with radiation. This study will also determine what
effects, good and/or bad, this drug has.
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.
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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