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

October 13, 2005
April 22, 2009
January 2003
Not Provided
  • Part A: Safety (incidence of DLTs)
  • Part B: Tolerability
Same as current
Complete list of historical versions of study NCT00239291 on ClinicalTrials.gov Archive Site
EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis
Same as current
Not Provided
Not Provided
 
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer
A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Metastatic Prostate Cancer
Drug: Gefitinib, radiotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
May 2006
Not Provided

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00239291
1839IL/0118
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Finland Medical Director, MD AstraZeneca
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP