Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00239291
NCT00239291
Completed
Phase 1

A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate Cancer

AstraZeneca1 site in 1 country42 target enrollmentJanuary 2003
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsNon-Metastatic Prostate Cancer
DrugsGefitinib, radiotherapy

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Non-Metastatic Prostate Cancer
Sponsor
AstraZeneca
Enrollment
42
Locations
1
Primary Endpoint
Part A: Safety (incidence of DLTs)
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2003
End Date
May 2006
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Part A: Safety (incidence of DLTs)

Part B: Tolerability

Secondary Outcomes

  • EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 1
A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung CancerNon-small-cell Lung Cancer
NCT00255489AstraZeneca36
Completed
Phase 1
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal CancerColorectal Cancer
NCT00026364National Cancer Institute (NCI)22
Terminated
Phase 1
Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck CancerHead and Neck Cancer
NCT00195078Weill Medical College of Cornell University29
Completed
Phase 1
ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung CancerNon Small Cell Lung Carcinoma
NCT00252798AstraZeneca44
Completed
Phase 1
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung CancerNon-Small Cell Lung Carcinoma (NSCLC)
NCT00328562Sidney Kimmel Cancer Center at Thomas Jefferson University13