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Completed

NCT Number: NCT00265070

Trial of Iressa in Prostate Cancer Patients

This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Removal of prostate for prostate cancer
  • Raised level of prostate specific antigen (PSA) post-surgery
  • Can have received some radiation therapy

Exclusion criteria

  • Any after surgery male hormone blocking therapy.
  • Low white blood cell count
  • Abnormal liver function test

Treatment and study plan

Gefitinib

Drug

250 mg tablet oral daily dose

Other names: Iressa®, ZD1839

Primary outcomes

  1. The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate

Secondary outcomes

  1. To estimate the duration of PSA response

  2. To estimate the partial PSA response rate

  3. To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline

  4. To investigate the change in PSA levels after discontinuation of ZD1839

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy

Important dates

Study start
2003
Study completion
2011
First posted
Dec 14, 2005
Registry last updated
Feb 5, 2013

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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