Trial of Iressa in Prostate Cancer Patients
Phase 2
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00265070
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
Inclusion Criteria
- Removal of prostate for prostate cancer
- Raised level of prostate specific antigen (PSA) post-surgery
- Can have received some radiation therapy
Exclusion Criteria
- Any after surgery male hormone blocking therapy.
- Low white blood cell count
- Abnormal liver function test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate
- Secondary Outcome Measures
Name Time Method To estimate the duration of PSA response To estimate the partial PSA response rate To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline To investigate the change in PSA levels after discontinuation of ZD1839
Trial Locations
- Locations (1)
Research Site
🇨🇦Montreal, Canada