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

• ClinicalTrials.gov Identifier: NCT00412217
• Recruitment Status: Terminated
• First Posted: December 18, 2006
• Results First Posted: September 26, 2016
• Last Update Posted: November 25, 2016
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Drug: Placebo; Drug: Erlotinib; Other: Standard of care	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: November 2006
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

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 Name: 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.	Drug: Placebo; Participants will receive placebo tablets (matched to erlotinib) once daily.; 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Disease Progression [ Time Frame: From inclusion in the study until disease progression (maximum up to 3 years overall) ]
   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.
2. Time to Progression (TTP) [ 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) ]
   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 :

1. Number of Participants Who Died [ Time Frame: From inclusion in the study until death from any cause (maximum up to 3 years overall) ]
   The number of participants who died from any cause was reported.
2. Overall Survival (OS) [ Time Frame: From inclusion in the study until death from any cause (maximum up to 3 years overall) ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Spain

Alcorcon, Spain, 28922

Barcelona, Spain, 08025

Barcelona, Spain, 08036

Barcelona, Spain, 08907

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, 28007

Madrid, Spain, 28033

Madrid, Spain, 28040

Madrid, Spain, 28041

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, 41009

Sevilla, Spain, 41013

Toledo, Spain, 45004

Valencia, Spain, 41014

Valencia, Spain, 46015

Valencia, Spain, 46026

Zamora, Spain, 49021

Zaragoza, Spain, 50009

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00412217
• Other Study ID Numbers: ML20294; 2006-001845-33 ( EudraCT Number )
• First Posted: December 18, 2006
• Results First Posted: September 26, 2016
• Last Update Posted: November 25, 2016
• Last Verified: October 2016

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Erlotinib Hydrochloride; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action