A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Erlotinib; Other: Standard of care; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Alcorcon, Spain, 28922
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08907
  • Barcelona, Spain, 08025
  • Barcelona, Spain, 08916
  • Burgos, Spain, 09005
  • Cordoba, Spain, 14004
  • Granada, Spain, 18014
  • Guadalajara, Spain, 19002
  • Jaen, Spain, 23007
  • Lugo, Spain, 27004
  • Madrid, Spain, 28006
  • Madrid, Spain, 28040
  • Madrid, Spain, 28041
  • Madrid, Spain, 28007
  • Madrid, Spain, 28033
  • Murcia, Spain, 30008
  • Orense, Spain, 32005
  • Palma de Mallorca, Spain, 07014
  • Salamanca, Spain, 37007
  • San Sebastian, Spain, 20012
  • San Sebastian, Spain, 20080
  • Santander, Spain, 39008
  • Sevilla, Spain, 41013
  • Sevilla, Spain, 41009
  • Toledo, Spain, 45004
  • Valencia, Spain, 46026
  • Valencia, Spain, 41014
  • Valencia, Spain, 46015
  • Zamora, Spain, 49021
  • Zaragoza, Spain, 50009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erlotinib; 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.	Drug: Erlotinib; Erlotinib will be given as 150 mg PO once daily.; Other Names: Tarceva; Other: Standard of care; 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.
Placebo Comparator: Placebo; Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.	Other: Standard of care; 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.; Drug: Placebo; Participants will receive placebo tablets (matched to erlotinib) once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From inclusion in the study until disease progression (maximum up to 3 years overall)
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Died	The number of participants who died from any cause was reported.	From inclusion in the study until death from any cause (maximum up to 3 years overall)
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.	From inclusion in the study until death from any cause (maximum up to 3 years overall)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 15, 2006
• First Submitted That Met QC Criteria: December 15, 2006
• First Posted (Estimate): December 18, 2006

Study Record Updates

• Last Update Posted (Estimate): November 25, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: ML20294; 2006-001845-33 (EudraCT Number)