Status:
COMPLETED
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Non-Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00239291
Start Date
January 1 2003
End Date
May 1 2006
Last Update
April 23 2009
Active Locations (1)
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1
Research site
Helsinki, Finland