Open Label Trial to Assess Iressa in Prostate Cancer Patients

This study has been completed.

First Received: March 7, 2008 Last Updated: April 22, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00635856

Purpose

A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels

Condition	Intervention	Phase
Prostate Cancer	Drug: Gefitinib	Phase II

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Pharmacodynamics Study
Official Title:	Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Serum Prostate Specific Antigen [ Time Frame: Monthly ]

Secondary Outcome Measures:

Duration of PSA decline [ Time Frame: Monthly ]
Safety variables [ Time Frame: Monthly ]
Time to Progression [ Time Frame: Every 3 months ]

Estimated Enrollment:	100
Study Start Date:	May 2001
Study Completion Date:	February 2003

Intervention Details:

Iressa

Eligibility

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

Criteria

Inclusion Criteria:

Prostate cancer diagnosis
no evidence of metastasis
Age 18 or older

Exclusion Criteria:

Prior chemotherapy for recurrent prostate cancer
Radiotherapy completed within 28 days of starting the study
Incomplete healing from prior cancer or other major surgery

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	AstraZeneca ( Alison Armour Medical Science Director )
Study ID Numbers:	1839US/0040
Study First Received:	March 7, 2008
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00635856 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Iressa
Gefitinib
Prostate Cancer
PSA

Study placed in the following topic categories:

Testosterone
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Methyltestosterone
Genital Diseases, Male

Protein Kinase Inhibitors
Gefitinib
Prostatic Neoplasms
Recurrence
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Urogenital Neoplasms
Enzyme Inhibitors
Genital Diseases, Male

Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Gefitinib

ClinicalTrials.gov processed this record on September 10, 2009