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

Roche

Status and phase: Terminated; Phase 3

Conditions: Head and Neck Cancer

Treatments: Drug: Placebo; Drug: Erlotinib; Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412217

2006-001845-33 (EudraCT Number)

ML20294

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups, including a placebo group

Erlotinib

Experimental group

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.

Treatment:

Other: Standard of care

Drug: Erlotinib

Placebo

Placebo Comparator group

Description:

Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.

Treatment:

Other: Standard of care

Drug: Placebo