ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025116
Recruitment Status : Completed
First Posted : September 17, 2003
Last Update Posted : November 9, 2010
Information provided by:
Canadian Cancer Trials Group

Brief Summary:

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more effective in treating prostate cancer that has not responded to hormone therapy.

PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients who have prostate cancer that has not responded to hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: gefitinib Phase 2

Detailed Description:


  • Compare the efficacy of 2 different doses of ZD 1839, in terms of objective response, PSA response, and duration of response, in patients with hormone-refractory adenocarcinoma of the prostate.
  • Compare the tolerability and quantitative toxicity of these regimens in these patients.
  • Determine whether there is an association between any response or stable disease and clinical benefit as assessed by changes in quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral, low-dose ZD 1839 twice daily on day 1 and once daily on days 2-28 during course 1 and then once daily on days 1-28 during subsequent courses.
  • Arm II: Patients receive oral, high-dose ZD 1839 as in arm I. Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of each course during study, and then at 4 weeks after study.

Patients with stable or responding disease are followed at 4 weeks and then every 3 months until disease progression. All other patients are followed at 4 weeks only.

PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
Study Start Date : April 2001
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • PSA at least 20 ng/mL at study entry
  • Must have documented evidence of disease progression, defined by 1 of the following conditions:

    • Rising PSA documented after discontinuation of peripheral antiandrogens

      • Minimum evidence of progression is a 25% increase in PSA over the reference value, provided that the increase is at least 5 ng/mL

        • Must have a first increase in PSA documented at least 1 week after the reference value and a second increase in PSA documented at least 1 week after the first increase
    • Progressive measurable disease during androgen ablative therapy (including medical or surgical castration)
  • Castrate level (no greater than 50 ng/mL) of testosterone required if receiving medical androgen-ablative therapy at study entry
  • Concurrent luteinizing hormone-releasing hormone agonist therapy required if receiving this medication at study entry



  • 16 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN (5 times ULN if documented liver metastases)


  • Creatinine no greater than 2 times ULN


  • No other malignancy within the past 5 years
  • No active uncontrolled bacterial, fungal, or viral infection
  • No significant neurological disorder that would preclude informed consent
  • No other serious illness or medical condition that would preclude study


Biologic therapy:

  • Concurrent epoetin alfa allowed


  • No prior chemotherapy
  • No concurrent cytotoxic therapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior peripheral antiandrogens (6 weeks for bicalutamide)
  • Concurrent steroids allowed if on stable dose for at least 4 weeks before study and no dose increase planned


  • At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy approved by the National Cancer Institute of Canada, Clinical Trials Group


  • See Disease Characteristics
  • No concurrent ophthalmic surgery


  • No prior investigational agents
  • No other concurrent investigational therapy
  • No concurrent ketoconazole
  • No concurrent high-dose narcotic therapy for pain (e.g., morphine equivalent dose more than 60 mg/day)
  • Concurrent bisphosphonates allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025116

Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Ontario Cancer Institute
Toronto, Ontario, Canada, M4X 1K9
Sponsors and Collaborators
NCIC Clinical Trials Group
Study Chair: Malcolm J. Moore, MD Princess Margaret Hospital, Canada

Publications of Results: Identifier: NCT00025116     History of Changes
Other Study ID Numbers: I140
CDR0000068915 ( Other Identifier: PDQ )
First Posted: September 17, 2003    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action