Head and Neck Cancer
Conditions
Keywords
Resectable, recurrent head and neck cancer
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.
Detailed description
An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.
Interventions
DRUGErlotinib
150 mg per day by mouth for 12 months
Sponsors
Genentech, Inc.
OSI Pharmaceuticals
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | 12 - 24 months | Number of participants who had the most frequently observed undesirable effects after exposure to study drug |
| Percentage of Participants With Disease Free Status at 12 Months and 24 Months | 12 - 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Demonstrating Survival at 12 Months and 24 Months. | 12 - 24 months | Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tarceva All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | discontinued due to medical condition | 3 |
| Overall Study | discontinued due to noncompliance | 2 |
| Overall Study | discontinued due to recurrence | 8 |
Baseline characteristics
| Characteristic | Tarceva |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| ECOG performance status 0 | 18 participants |
| ECOG performance status 1 | 8 participants |
| ECOG performance status 2 | 2 participants |
| ECOG performance status unknown | 3 participants |
| Extent of recurrence Local | 21 participants |
| Extent of recurrence Locoregional | 5 participants |
| Extent of recurrence Regional | 5 participants |
| Flap reconstruction No | 4 participants |
| Flap reconstruction Yes | 27 participants |
| Histological features Lymphovascular invasion present | 4 participants |
| Histological features None | 13 participants |
| Histological features Perineural invasion present | 10 participants |
| Histological features Positive lymph nodes | 4 participants |
| Histological tumor grade Moderately differentiated | 14 participants |
| Histological tumor grade Not specified | 9 participants |
| Histological tumor grade Poorly differentiated | 7 participants |
| Histological tumor grade Well differentiated | 1 participants |
| Neck dissection Bilateral | 12 participants |
| Neck dissection None | 10 participants |
| Neck dissection Unilateral | 9 participants |
| Procedure details Coincident PEG | 11 participants |
| Procedure details Coincident tracheostomy | 13 participants |
| Procedure details None | 7 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 18 Participants |
| Tumor Stage at Study Start - Primary Tumor Stage (T) not specified | 8 participants |
| Tumor Stage at Study Start - Primary Tumor Stage (T) T1 | 1 participants |
| Tumor Stage at Study Start - Primary Tumor Stage (T) T2 | 3 participants |
| Tumor Stage at Study Start - Primary Tumor Stage (T) T3 | 6 participants |
| Tumor Stage at Study Start - Primary Tumor Stage (T) T4 | 13 participants |
| Tumor Stage at Study Start - Regional Metastasis (N) N0 | 18 participants |
| Tumor Stage at Study Start - Regional Metastasis (N) N1 | 2 participants |
| Tumor Stage at Study Start - Regional Metastasis (N) N2 | 2 participants |
| Tumor Stage at Study Start - Regional Metastasis (N) N3 | 1 participants |
| Tumor Stage at Study Start - Regional Metastasis (N) not specified | 8 participants |
| Tumor subsite hypopharynx | 3 participants |
| Tumor subsite larynx | 7 participants |
| Tumor subsite oral cavity | 11 participants |
| Tumor subsite oropharynx | 9 participants |
| Tumor subsite unknown | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 31 |
| serious Total, serious adverse events | 9 / 31 |
Outcome results
Primary
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
Time frame: 12 - 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tarceva | Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | rash | 26 participants |
| Tarceva | Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | diarrhea | 22 participants |
| Tarceva | Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | fatigue | 22 participants |
| Tarceva | Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | nausea | 6 participants |
| Tarceva | Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | vomiting | 6 participants |
| Tarceva | Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment | headache | 4 participants |
Primary
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)
Time frame: 12 - 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tarceva | Percentage of Participants With Disease Free Status at 12 Months and 24 Months | disease free rate at 12 months | 54 percentage of participants |
| Tarceva | Percentage of Participants With Disease Free Status at 12 Months and 24 Months | disease free rate at 24 months | 45 percentage of participants |
Secondary
Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy
Time frame: 12 - 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tarceva | Percentage of Participants Demonstrating Survival at 12 Months and 24 Months. | survival rate at 12 months | 61 percentage of participants |
| Tarceva | Percentage of Participants Demonstrating Survival at 12 Months and 24 Months. | survival rate at 24 months | 56 percentage of participants |