Head and Neck Cancer
Conditions
Keywords
squamous cell cancer of head and neck, SCCHN
Brief summary
Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent
Interventions
DRUGErlotinib
150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Sponsors
Genentech, Inc.
Geisinger Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage III, IV SCCHN * Completed curative treatment
Exclusion criteria
* Prior chemotherapy or radiotherapy * Recurrent disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One Year Disease Free | 1 year | Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables. |
Countries
United States
Participant flow
Pre-assignment details
After the enrollment of 4 participants in this study, the PI left Geisinger. Geisinger does not have any details regarding which Arm/Group participants were assigned to.
Participants by arm
| Arm | Count |
|---|---|
| One Year Disease Free Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
One Year Disease Free
Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table.
Time frame: 1 year
Population: Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.
Secondary
Overall Survival
Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.
Time frame: 2 years
Population: Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.