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

Non-Metastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239291
• Other study ID #: 1839IL/0118
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 13, 2005
• Last updated: April 22, 2009
• Start date: January 2003
• Est. completion date: May 2006

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Non-Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Gefitinib, radiotherapy

Locations

Country	Name	City	State
Finland	Research site	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Safety (incidence of DLTs)
Primary	Part B: Tolerability
Secondary	EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis