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

Phase 1

Completed

• Conditions: Non-Metastatic Prostate Cancer

• Registration Number: NCT00239291
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Study Completion: 2006-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Part A: Safety (incidence of DLTs)
Part B: Tolerability

Secondary Outcome Measures

Name	Time	Method
EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis

Trial Locations

Locations (1)

Research site; 🇫🇮 Helsinki, Finland