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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Intervention Drug: Erlotinib
Enrollment 4
Recruitment Details  
Pre-assignment Details After the enrollment of 4 participants in this study, the PI left Geisinger. Geisinger does not have any details regarding which Arm/Group participants were assigned to.
Arm/Group Title One Year Disease Free
Hide Arm/Group Description Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title One Year Disease Free
Hide Arm/Group Description Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
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 baseline analysis population.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title One Year Disease Free
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title One Year Disease Free
Hide Arm/Group Description:
Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Overall Survival
Hide Arm/Group Description:
Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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 to report in Adverse Events.
 
Arm/Group Title One Year Disease Free
Hide Arm/Group Description Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
All-Cause Mortality
One Year Disease Free
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
One Year Disease Free
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
One Year Disease Free
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Office of Research Compliance
Organization: Geisinger
Phone: 570-214-9628
EMail: orc@geisinger.edu
Layout table for additonal information
Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT00750555    
Other Study ID Numbers: 2008-0153
OSI4178S
First Submitted: September 9, 2008
First Posted: September 10, 2008
Results First Submitted: January 14, 2019
Results First Posted: February 5, 2019
Last Update Posted: February 26, 2019