Trial Information
A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Part A: Safety (incidence of DLTs)
Principal Investigator
AstraZeneca Finland Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Finland: Finnish Medicines Agency
Study ID:
1839IL/0118
NCT ID:
NCT00239291
Start Date:
January 2003
Completion Date:
May 2006
Related Keywords:
- Non-Metastatic Prostate Cancer
- Prostatic Neoplasms