Trial of Iressa in Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265070
• Other study ID #: 1839IL/0093
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2005
• Last updated: February 4, 2013
• Start date: January 2003
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Gefitinib
250 mg tablet oral daily dose

Locations

Country	Name	City	State
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To estimate the duration of PSA response
Secondary	To estimate the partial PSA response rate
Secondary	To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
Secondary	To investigate the change in PSA levels after discontinuation of ZD1839