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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: Gefitinib, radiotherapy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Overall Official(s)
    • AstraZeneca Finland Medical Director, MD, Study Director, AstraZeneca

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