Back to resultsTrial of Iressa in Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00265070
Brief Title
Trial of Iressa in Prostate Cancer Patients
Official Title
An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
Iressa®, ZD1839
Intervention Description
250 mg tablet oral daily dose
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To estimate the duration of PSA response
Title
To estimate the partial PSA response rate
Title
To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
Title
To investigate the change in PSA levels after discontinuation of ZD1839
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Canada Oncology Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Trial of Iressa in Prostate Cancer Patients
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