Open Label Trial to Assess Iressa in Prostate Cancer Patients

Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635856

Enrollment

100

Registered

2008-03-14

Start date

2001-05-31

Completion date

2003-02-28

Last updated

2009-04-23

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

Conditions

Prostate Cancer

Keywords

Iressa, Gefitinib, Prostate Cancer, PSA

Brief summary

A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels

Interventions

DRUGGefitinib

Iressa

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Prostate cancer diagnosis * no evidence of metastasis * Age 18 or older

Exclusion criteria

* Prior chemotherapy for recurrent prostate cancer * Radiotherapy completed within 28 days of starting the study * Incomplete healing from prior cancer or other major surgery

Design outcomes

Primary

Measure	Time frame
Serum Prostate Specific Antigen	Monthly

Secondary

Measure	Time frame
Duration of PSA decline	Monthly
Safety variables	Monthly
Time to Progression	Every 3 months

Outcome results

None listed

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