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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)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT00750555
First received: September 9, 2008
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

  • Stage III, IV SCCHN
  • Completed curative treatment

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy
  • Recurrent disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750555

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

Additional Information:
Click here for more information about Geisinger Health System  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Geisinger Clinic
ClinicalTrials.gov 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
SCCHN

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

ClinicalTrials.gov processed this record on May 16, 2013