Clinical trial · Interventional
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
NCT00570232CI-TRIAL-00017986UAB0718completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Tarceva
- description
- All patients will be prescribed erlotinib 150mg daily
- interventionNames
- Drug: Erlotinib
Primary outcomes (2)
- measure
- Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
- timeFrame
- 12 - 24 months
- description
- Number of participants who had the most frequently observed undesirable effects after exposure to study drug
- measure
- Percentage of Participants With Disease Free Status at 12 Months and 24 Months
- timeFrame
- 12 - 24 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.