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

• ClinicalTrials.gov Identifier: NCT00750555
• Recruitment Status: Terminated
• First Posted: September 10, 2008
• Results First Posted: February 5, 2019
• Last Update Posted: February 26, 2019
• Sponsor: Geisinger Clinic
• Collaborator: Genentech, Inc.
• Information provided by (Responsible Party): Geisinger Clinic

Tracking Information

• First Submitted Date: September 9, 2008
• First Posted Date: September 10, 2008
• Results First Submitted Date: January 14, 2019
• Results First Posted Date: February 5, 2019
• Last Update Posted Date: February 26, 2019
• Study Start Date: September 2008
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 9, 2008): One Year Disease Free [ Time Frame: 1 year ]

Current Secondary Outcome Measures (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 (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: Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2
• 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

150 mg per day orally until disease progression occurs, up to a maximum of 12 months

Other Name: Tarceva

Study Arms

1

Intervention: Drug: Erlotinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 30, 2011): 4
• Original Estimated Enrollment (submitted: September 9, 2008): 42
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Stage III, IV SCCHN
• Completed curative treatment

Exclusion Criteria:

• Prior chemotherapy or radiotherapy
• Recurrent disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00750555
• Other Study ID Numbers: 2008-0153; OSI4178S
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Geisinger Clinic
• Study Sponsor: Geisinger Clinic
• Collaborators: Genentech, Inc.

Investigators

• Principal Investigator: Amy Law, MD; Geisinger Clinic

• PRS Account: Geisinger Clinic
• Verification Date: February 2019