Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014183
Status:
COMPLETED
Last Update Posted:
2019-11-07
First Post:
2001-04-10
Brief Title:
ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase II Study Of ZD1839 NSC 715055 In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
Status:
COMPLETED
Status Verified Date:
2019-11
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 kidney cancer
PURPOSE Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer
PURPOSE Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer
Detailed Description:
OBJECTIVES
Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839
Determine the median time to objective progression in these patients receiving this drug
Determine the toxic effects of this drug in this patient population
Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients
OUTLINE This is a multicenter study
Patients receive oral ZD 1839 daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 11-23 months
Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839
Determine the median time to objective progression in these patients receiving this drug
Determine the toxic effects of this drug in this patient population
Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients
OUTLINE This is a multicenter study
Patients receive oral ZD 1839 daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 11-23 months
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 |
|---|---|---|---|
| NCI-1639 | None | None | None |
| MSGCC-0044 | None | None | None |