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

Sponsor
NCIC Clinical Trials Group (Other)
Overall Status
Completed
CT.gov ID
NCT00025116
Collaborator
(none)
40
Enrollment
2
Locations
89
Actual Duration (Months)
20
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Detailed Description

OBJECTIVES:

  • 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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
Actual Study Start Date :
Apr 24, 2001
Actual Primary Completion Date :
Jun 5, 2003
Actual Study Completion Date :
Sep 22, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 120 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • 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

    PATIENT CHARACTERISTICS:
    Age:
    • 16 and over
    Performance status:
    • ECOG 0-1
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Absolute granulocyte count at least 1,500/mm3

    • Platelet count at least 100,000/mm3

    Hepatic:

    • 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)

    Renal:
    • Creatinine no greater than 2 times ULN
    Other:

    • 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

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Concurrent epoetin alfa allowed
    Chemotherapy:

    • 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

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

    • See Disease Characteristics

    • No concurrent ophthalmic surgery

    Other:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
    2 Ontario Cancer Institute Toronto Ontario Canada M4X 1K9

    Sponsors and Collaborators

    • NCIC Clinical Trials Group

    Investigators

    • Study Chair: Malcolm J. Moore, MD, Princess Margaret Hospital, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NCIC Clinical Trials Group
    ClinicalTrials.gov Identifier:
    NCT00025116
    Other Study ID Numbers:
    • I140
    • CAN-NCIC-IND140
    • CDR0000068915
    First Posted:
    Sep 17, 2003
    Last Update Posted:
    Apr 6, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NCIC Clinical Trials Group
    adenocarcinoma of the prostate
    recurrent prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Gefitinib

    Study Results

    No Results Posted as of Apr 6, 2020