Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Cisplatin; Gefitinib

Criteria

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