NCT00750555

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

September 9, 2008

Results QC Date

January 14, 2019

Last Update Submit

February 4, 2019

Conditions

Head and Neck Cancer

Keywords

squamous cell cancer of head and neckSCCHN

Outcome Measures

Primary Outcomes (1)

  • One Year Disease Free

    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.

    1 year

Secondary Outcomes (1)

  • Overall Survival

    2 years

Study Arms (1)

1

OTHER
Drug: Erlotinib

Interventions

ErlotinibDRUG

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

Also known as: Tarceva
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage III, IV SCCHN
  • Completed curative treatment

You may not qualify if:

  • Prior chemotherapy or radiotherapy
  • Recurrent disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Office of Research Compliance
Organization
Geisinger
orc@geisinger.edu
570-214-9628

Study Officials

  • Amy Law, MD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 26, 2019

Results First Posted

February 5, 2019

Record last verified: 2019-02

Locations

US(1)