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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Non-Metastatic Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part A: Safety (incidence of DLTs)

Principal Investigator

AstraZeneca Finland Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Finland: Finnish Medicines Agency

Study ID:

1839IL/0118

NCT ID:

NCT00239291

Start Date:

January 2003

Completion Date:

May 2006

Related Keywords:

  • Non-Metastatic Prostate Cancer
  • Prostatic Neoplasms

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