Trial of Iressa in Prostate Cancer Patients

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00265070

Enrollment

Registered

2005-12-14

Start date

2003-01-31

Completion date

2011-08-31

Last updated

2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

DRUGGefitinib

250 mg tablet oral daily dose

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026