Back to resultsA Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Erlotinib
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Adults greater than or equal to (≥) 18 years of age
- Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
- Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Exclusion Criteria:
- Macroscopic residual disease after surgery
- Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Erlotinib
Placebo
Arm Description
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
Outcomes
Primary Outcome Measures
Number of Participants With Disease Progression
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.
Time to Progression (TTP)
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.
Secondary Outcome Measures
Number of Participants Who Died
The number of participants who died from any cause was reported.
Overall Survival (OS)
OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00412217
Brief Title
A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
Official Title
Phase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because recruitment was too slow.
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib
Arm Type
Experimental
Arm Description
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo tablets (matched to erlotinib) once daily.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib will be given as 150 mg PO once daily.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.
Primary Outcome Measure Information:
Title
Number of Participants With Disease Progression
Description
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.
Time Frame
From inclusion in the study until disease progression (maximum up to 3 years overall)
Title
Time to Progression (TTP)
Description
Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.
Time Frame
From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)
Secondary Outcome Measure Information:
Title
Number of Participants Who Died
Description
The number of participants who died from any cause was reported.
Time Frame
From inclusion in the study until death from any cause (maximum up to 3 years overall)
Title
Overall Survival (OS)
Description
OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.
Time Frame
From inclusion in the study until death from any cause (maximum up to 3 years overall)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults greater than or equal to (≥) 18 years of age
Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Exclusion Criteria:
Macroscopic residual disease after surgery
Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Burgos
ZIP/Postal Code
09005
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
City
Jaen
ZIP/Postal Code
23007
Country
Spain
City
Lugo
ZIP/Postal Code
27004
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Murcia
ZIP/Postal Code
30008
Country
Spain
City
Orense
ZIP/Postal Code
32005
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
San Sebastian
ZIP/Postal Code
20012
Country
Spain
City
San Sebastian
ZIP/Postal Code
20080
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Toledo
ZIP/Postal Code
45004
Country
Spain
City
Valencia
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Zamora
ZIP/Postal Code
49021
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
We'll reach out to this number within 24 hrs