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

Head and Neck Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00412217
• Other study ID #: ML20294
• Status: Terminated
• Phase: Phase 3
• First received: December 15, 2006
• Last updated: February 1, 2016
• Start date: November 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• high risk totally resected head and neck squamous cell cancer: T3-T4 or N2-N3;

• ECOG <=2.

Exclusion Criteria:

• macroscopic residual disease after surgery;

• previous treatment with anti-EGFR.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Standard of care treatment
As prescribed
• erlotinib [Tarceva]
150mg po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Event driven	No
Secondary	Overall survival		Event driven	No
Secondary	AEs		Throughout study	No