Trial Information

Summary: A Study of Tarceva (Erlotinib) in Patients With Resected Head and Neck Squamous Cell Cancer.

Status: Recruiting

Protocol Number: ML20294

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open label, study of the effect of Tarceva on progression free survival when given as maintenance treatment following concurrent chemo-radiotherapy or radiotherapy alone in patients with resected head and neck squamous cell cancer

Brief Summary: This 2 arm study will compare the efficacy and safety of Tarceva, versus standard of care, in patients with resected head and neck squamous cell cancer who are receiving concurrent chemo-radiotherapy or radiotherapy alone. Patients will be randomized to receive either Tarceva 150mg po daily or standard of care. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 300.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Head and Neck Cancer

Intervention Type: Drug

Intervention Name: erlotinib[Tarceva]

Primary Outcome: 1. Progression-free survival Time frame: Event driven

Key Secondary Outcomes: 1. Overall survival Time frame: Event driven 2. AEs Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: November, 2006

Trial Registration Date: 12/18/2006

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:30:38 PM