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Trial of Iressa in Prostate Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00265070
First received: December 12, 2005
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Gefitinib
U.S. FDA Resources

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: August 2011
Intervention Details:
    Drug: Gefitinib
    250 mg tablet oral daily dose
    Other Names:
    • Iressa®
    • ZD1839
  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, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada
Research Site
Montreal, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Canada Oncology Medical Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00265070     History of Changes
Other Study ID Numbers: 1839IL/0093
Study First Received: December 12, 2005
Last Updated: February 4, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 16, 2013