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Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239291
First received: October 13, 2005
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer


Condition Intervention Phase
Non-Metastatic Prostate Cancer
 Drug: Gefitinib, radiotherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer

Resource links provided by NLM:

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Part A: Safety (incidence of DLTs)
  • Part B: Tolerability

Secondary Outcome Measures:
  • EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis

Enrollment: 42
Study Start Date: January 2003
Study Completion Date: May 2006
  Eligibility

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

Inclusion Criteria:

  • Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
  • PSA below 20 ng/mL
  • Lymph node negative
  • Non-metastatic
  • Written informed consent

Exclusion Criteria:

  • Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
  • Distant or nodal metastases
  • Prostatectomy
  • Concomitant LHRH analog treatment
  • Previous or concomitant anti-androgens
  • Active ILD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239291

Locations
Finland
Research site
Helsinki, Finland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Finland Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00239291     History of Changes
Other Study ID Numbers: 1839IL/0118
Study First Received: October 13, 2005
Last Updated: April 22, 2009
Health Authority: Finland: Finnish Medicines Agency

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