Trial of Iressa in Prostate Cancer Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00265070

Purpose

This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.

Condition	Intervention	Phase
Prostate Cancer	Drug: Gefitinib	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate

Secondary Outcome Measures:

To estimate the duration of PSA response
To estimate the partial PSA response rate
To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
To investigate the change in PSA levels after discontinuation of ZD1839

Enrollment:	80
Study Start Date:	January 2003
Study Completion Date:	December 2007

Intervention Details:

250 mg tablet oral daily dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Removal of prostate for prostate cancer
Raised level of prostate specific antigen (PSA) post-surgery
Can have received some radiation therapy

Exclusion Criteria:

Any after surgery male hormone blocking therapy.
Low white blood cell count
Abnormal liver function test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265070

Locations

Canada
Research Site
Montreal, Canada
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Canada Oncology Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839IL/0093
Study First Received:	December 12, 2005
Last Updated:	December 16, 2007
ClinicalTrials.gov Identifier:	NCT00265070
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Gefitinib
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009