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
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