Back to resultsSafety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer
Primary Purpose
Non-Metastatic Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Gefitinib, radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-Metastatic Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Research site
Outcomes
Primary Outcome Measures
Part A: Safety (incidence of DLTs)
Part B: Tolerability
Secondary Outcome Measures
EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00239291
Brief Title
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer
Official Title
A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Metastatic Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib, radiotherapy
Primary Outcome Measure Information:
Title
Part A: Safety (incidence of DLTs)
Title
Part B: Tolerability
Secondary Outcome Measure Information:
Title
EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Finland Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer
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