ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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|ClinicalTrials.gov Identifier: NCT00025116|
Recruitment Status : Completed
First Posted : September 17, 2003
Last Update Posted : November 9, 2010
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|
- 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)|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00025116
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Ontario Cancer Institute|
|Toronto, Ontario, Canada, M4X 1K9|
|Study Chair:||Malcolm J. Moore, MD||Princess Margaret Hospital, Canada|