Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239291

Enrollment

Registered

2005-10-17

Start date

2003-01-31

Completion date

2006-05-31

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

Non-Metastatic Prostate Cancer

Brief summary

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer

Interventions

DRUGGefitinib, radiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Part A: Safety (incidence of DLTs)	—
Part B: Tolerability	—

Secondary

Measure	Time frame
EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis	—

Countries

Finland

Outcome results

None listed

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