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

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ClinicalTrials.gov Identifier: NCT00750555
Recruitment Status : Terminated (Dr. Amy Law left Geisinger Health System. 4 patients enrolled)
First Posted : September 10, 2008
Last Update Posted : October 11, 2012
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Geisinger Clinic

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Study Start Date : September 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1 Drug: Erlotinib
150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Other Name: Tarceva



Primary Outcome Measures :
  1. One year disease free [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage III, IV SCCHN
  • Completed curative treatment

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy
  • Recurrent disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750555


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

Additional Information:
Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT00750555     History of Changes
Other Study ID Numbers: 2008-0153
OSI4178S
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action