Phase 2
Completed N=31
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Source: ClinicalTrials.gov NCT00570232 ↗Enrolled (actual)
31
Serious AEs
29.0%
Results posted
May 2015
Primary outcomePrimary: Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment — 26; 22; 22; 6 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment |
26; 22; 22; 6; 6; 4 | — |
| PRIMARY Percentage of Participants With Disease Free Status at 12 Months and 24 Months |
54; 45 | — |
| SECONDARY Percentage of Participants Demonstrating Survival at 12 Months and 24 Months. |
61; 56 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00570232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.