Back to resultsMaintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring squamous cell cancer of head and neck, SCCHN
Eligibility Criteria
Inclusion Criteria:
- Stage III, IV SCCHN
- Completed curative treatment
Exclusion Criteria:
- Prior chemotherapy or radiotherapy
- Recurrent disease
Sites / Locations
- Geisinger Health System
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00750555
First Posted
September 9, 2008
Last Updated
February 4, 2019
Sponsor
Geisinger Clinic
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00750555
Brief Title
Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Official Title
Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
PI Law left Geisinger-study terminated prematurely - 4 patients enrolled
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
squamous cell cancer of head and neck, SCCHN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Primary Outcome Measure Information:
Title
One Year Disease Free
Description
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
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III, IV SCCHN
Completed curative treatment
Exclusion Criteria:
Prior chemotherapy or radiotherapy
Recurrent disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Law, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.geisinger.org
Description
Click here for more information about Geisinger Health System
Learn more about this trial
Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
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