Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014144
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
2001-04-10
Brief Title:
S0031 ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Evaluation of ZD1839 NSC 715055 for Advanced Transitional Cell Carcinoma of the Urothelium Phase II
Status:
COMPLETED
Status Verified Date:
2012-10
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 the tumor cells and slow the growth of cancer of the urinary tract
PURPOSE Phase II trial to study the effectiveness of ZD 1839 in treating patients who have advanced cancer of the urinary tract
PURPOSE Phase II trial to study the effectiveness of ZD 1839 in treating patients who have advanced cancer of the urinary tract
Detailed Description:
OBJECTIVES
Determine the 6-month progression-free survival rate of patients with advanced transitional cell carcinoma of the urothelium treated with ZD 1839
Determine the overall survival and response confirmed complete and partial response in these patients treated with this regimen
Determine the qualitative and quantitative toxicity of this regimen in these patients
Evaluate the changes in growth factor protein kinase expression before and after treatment and at the time of disease progression in these patients treated with this regimen
OUTLINE Patients receive oral ZD 1839 once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 30-55 patients will be accrued for this study
Determine the 6-month progression-free survival rate of patients with advanced transitional cell carcinoma of the urothelium treated with ZD 1839
Determine the overall survival and response confirmed complete and partial response in these patients treated with this regimen
Determine the qualitative and quantitative toxicity of this regimen in these patients
Evaluate the changes in growth factor protein kinase expression before and after treatment and at the time of disease progression in these patients treated with this regimen
OUTLINE Patients receive oral ZD 1839 once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 30-55 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0031 | OTHER | None | None |