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

Phase 3TerminatedNCT00412217

Hoffmann-La Roche94 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

PlaceboDRUG

Participants will receive placebo tablets (matched to erlotinib) once daily.

ErlotinibDRUG

Erlotinib will be given as 150 mg PO once daily.

Standard of careOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (31)

Unnamed facility

Alcorcón, Spain

Unnamed facility

Barcelona, Spain

Outcomes

Primary Outcomes

Number of Participants With Disease Progression

Time frame: 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.

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 Outcomes

Number of Participants Who Died

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)

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.

Time frame: From inclusion in the study until death from any cause (maximum up to 3 years overall)

Data from ClinicalTrials.gov

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