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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750555
Recruitment Status : Terminated (PI Law left Geisinger-study terminated prematurely - 4 patients enrolled)
First Posted : September 10, 2008
Results First Posted : February 5, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Geisinger Clinic

Tracking Information
First Submitted Date  ICMJE September 9, 2008
First Posted Date  ICMJE September 10, 2008
Results First Submitted Date  ICMJE January 14, 2019
Results First Posted Date  ICMJE February 5, 2019
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
One Year Disease Free [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
One Year Disease Free [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
Overall Survival [ Time Frame: 2 years ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
Overall Survival [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Official Title  ICMJE Phase II Study of Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
Brief Summary Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Drug: Erlotinib
150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Other Name: Tarceva
Study Arms  ICMJE 1
Intervention: Drug: Erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 30, 2011)
4
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2008)
42
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stage III, IV SCCHN
  • Completed curative treatment

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy
  • Recurrent disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00750555
Other Study ID Numbers  ICMJE 2008-0153
OSI4178S
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Geisinger Clinic
Study Sponsor  ICMJE Geisinger Clinic
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Amy Law, MD Geisinger Clinic
PRS Account Geisinger Clinic
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP