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

This study has been terminated.
(Dr. Amy Law left Geisinger Health System. 4 patients enrolled)
Genentech, Inc.
Information provided by (Responsible Party):
Geisinger Clinic Identifier:
First received: September 9, 2008
Last updated: October 10, 2012
Last verified: October 2012

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

Condition Intervention Phase
Head and Neck Cancer
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer

Resource links provided by NLM:

Further study details as provided by Geisinger Clinic:

Primary Outcome Measures:
  • One year disease free [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Erlotinib
150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Other Name: Tarceva


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage III, IV SCCHN
  • Completed curative treatment

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy
  • Recurrent disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00750555

United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Sponsors and Collaborators
Geisinger Clinic
Genentech, Inc.
Principal Investigator: Amy Law, MD Geisinger Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Geisinger Clinic Identifier: NCT00750555     History of Changes
Other Study ID Numbers: 2008-0153, OSI4178S
Study First Received: September 9, 2008
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Geisinger Clinic:
squamous cell cancer of head and neck

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on November 20, 2014