Official Title: “Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial”

To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Gefitinib
  • 250 mg; oral
• Drug: Gefitinib
  • 250mg; oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Cohort 1
  • post operative combination of gefinib and RT
• Experimental: Cohort 2
  • combination of gefitinib with RT and Chemotherapy in non operated patients

Primary Measures

• To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
  • Safety Issue?: No

Secondary Measures

• Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
  • Safety Issue?: No
• Cohort 1 only time-to-recurrence (TTR)
  • Safety Issue?: No
• Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)
  • Safety Issue?: No

Inclusion Criteria:

• Written informed consent
• Age over 18 years
• Histologically proven squamous cell cancer of the head & neck (SCCHN)
• Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3

Exclusion Criteria:

• Hypersensitivity to ZD1839 or any of the excipients of this product
• Tumour stage M1
• Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
• Absolute neutrophil counts <1.5 x 109

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Christoph Rochlitz, Prof Dr med Principal Investigator University Hospital of Basel  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00681967

Study ID Number: 1839IL/0525

ClinicalTrials.gov Identifier: NCT00681967

Health Authority: Switzerland: Swissmedic