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NCT00750555 Clinical Trial

Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00750555
Other study ID # 2008-0153
Secondary ID OSI4178S
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 2008
Est. completion date December 2009

Study information
Verified date February 2019
Source Geisinger Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Stage III, IV SCCHN

- Completed curative treatment

Exclusion Criteria:

- Prior chemotherapy or radiotherapy

- Recurrent disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Erlotinib
150 mg per day orally until disease progression occurs, up to a maximum of 12 months

Locations
Country Name City State
United States Geisinger Health System Danville Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Geisinger Clinic Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. 1 year
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. 2 years
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