Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

NCT ID: NCT00319787

Last Updated: 2011-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2006-08-31

Brief Summary

The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.

Conditions

Locally Advanced Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Iressa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma

Exclusion Criteria

• No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Norway Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca AS

Locations

Research Site

Moelv, , Norway

Research Site

Oslo, , Norway

Research Site

Trondheim, , Norway

Countries

Norway

Other Identifiers

1839IL/0129

Identifier Type: -

Identifier Source: org_study_id