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

NCT ID: NCT00239291

Last Updated: 2009-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-05-31

Brief Summary

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

Detailed Description

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Conditions

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Non-Metastatic Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib, radiotherapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Finland Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research site

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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1839IL/0118

Identifier Type: -

Identifier Source: org_study_id

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