Prostate CancerPhase 2NCT00025116
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase 2 study testing gefitinib in people with Prostate Cancer, run by NCIC Clinical Trials Group at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- gefitinib
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Apr 2001to 22 Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Ontario Cancer Institute
Toronto, Ontario, M4X 1K9
About this study
Official title: A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- gefitinib
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2003 (estimated)
- Study start24 Apr 2001
- Primary completion5 Jun 2003
- Study completion22 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Malcolm J. Moore, MD, Study chair, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025116
- Sponsor's protocol ID
- I140
- Other IDs
- CAN-NCIC-IND140, CDR0000068915
- Status last verified
- Apr 2020
- First submitted
- 11 Oct 2001
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15659491
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Of ZD1839 (IRESSA) In Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00025116
- Acronym / sponsor ID
- I140
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 24 Apr 2001 (actual)
- Primary completion
- 5 Jun 2003 (actual)
- Study completion
- 22 Sep 2008 (actual)
- First posted
- 17 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gefitinib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Results publication: PubMed 15659491Canil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm J. Moore, MD study chair
Princess Margaret Hospital, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gefitinib in people with Prostate Cancer, run by NCIC Clinical Trials Group at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00025116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.