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Open Label Trial to Assess Iressa in Prostate Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635856
First Posted: March 14, 2008
Last Update Posted: April 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 2

AstraZeneca has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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:


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:
    Drug: Gefitinib
    Iressa
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00635856     History of Changes
Obsolete Identifiers: NCT00033579
Other Study ID Numbers: 1839US/0040
First Submitted: March 7, 2008
First Posted: March 14, 2008
Last Update Posted: April 23, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Iressa
Gefitinib
Prostate Cancer
PSA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action