Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer

• PSA below 20 ng/mL

• Lymph node negative

• Non-metastatic

• Written informed consent

Exclusion Criteria:

• Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)

• Distant or nodal metastases

• Prostatectomy

• Concomitant LHRH analog treatment

• Previous or concomitant anti-androgens

• Active ILD