Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025116
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2001-10-11
Brief Title:
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase II Study Of ZD1839 IRESSA In Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068915 | OTHER | PDQ | None |
| CAN-NCIC-IND140 | OTHER | None | None |