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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
gefitinib
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

16 Years - 120 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • Ontario Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
April 2, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00025116
Brief Title
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2001 (Actual)
Primary Completion Date
June 5, 2003 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gefitinib

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm J. Moore, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Ontario Cancer Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1K9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15659491
Citation
Canil CM, Moore MJ, Winquist E, Baetz T, Pollak M, Chi KN, Berry S, Ernst DS, Douglas L, Brundage M, Fisher B, McKenna A, Seymour L. Randomized phase II study of two doses of gefitinib in hormone-refractory prostate cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group. J Clin Oncol. 2005 Jan 20;23(3):455-60. doi: 10.1200/JCO.2005.02.129.
Results Reference
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ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

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