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OpenTrials
Completed

NCT Number: NCT00239291

Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in 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

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Key information

Conditions

Non-Metastatic Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research site

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib, radiotherapy

Drug

Primary outcomes

  1. Part A: Safety (incidence of DLTs)

  2. Part B: Tolerability

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Oct 17, 2005
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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