Trial of Iressa in Prostate Cancer Patients

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. Identifier: NCT00265070
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Gefitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy
Study Start Date : January 2003
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Intervention Details:
    Drug: Gefitinib
    250 mg tablet oral daily dose
    Other Names:
    • Iressa®
    • ZD1839

Primary Outcome Measures :
  1. 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 :
  1. To estimate the duration of PSA response
  2. To estimate the partial PSA response rate
  3. To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
  4. To investigate the change in PSA levels after discontinuation of ZD1839

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265070

Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Canada
Sponsors and Collaborators
Study Director: AstraZeneca Canada Oncology Medical Director, MD AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT00265070     History of Changes
Other Study ID Numbers: 1839IL/0093
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

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