Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459979
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
2007-04-11
Brief Title:
Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors
Status:
COMPLETED
Status Verified Date:
2014-02
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 Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth
PURPOSE This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
To determine the percentage of patients with renal cell carcinoma and unresectable primary tumors who can achieve sufficient tumor response according to the operating surgeon to undergo nephrectomy after sunitinib therapy
To evaluate the safety of sunitinib in patients with renal cell carcinoma and unresectable primary tumors including analysis of the morbidity of surgery after sunitinib therapy
To evaluate the objective response rate of patients with renal cell carcinoma and unresectable primary tumors who receive sunitinib therapy
OUTLINE A single arm phase II study of sunitinib in patients with unresectable renal cell carcinoma RCC will be conducted including patients with and without distant metastases
Patients receive oral sunitinib malate once daily on days 1-28 Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity Surgery is performed if and when primary tumor becomes resectable Patients with residual andor metastatic disease may resume sunitinib malate within 8 weeks after surgery
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 31 patients will be accrued for this study
To determine the percentage of patients with renal cell carcinoma and unresectable primary tumors who can achieve sufficient tumor response according to the operating surgeon to undergo nephrectomy after sunitinib therapy
To evaluate the safety of sunitinib in patients with renal cell carcinoma and unresectable primary tumors including analysis of the morbidity of surgery after sunitinib therapy
To evaluate the objective response rate of patients with renal cell carcinoma and unresectable primary tumors who receive sunitinib therapy
OUTLINE A single arm phase II study of sunitinib in patients with unresectable renal cell carcinoma RCC will be conducted including patients with and without distant metastases
Patients receive oral sunitinib malate once daily on days 1-28 Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity Surgery is performed if and when primary tumor becomes resectable Patients with residual andor metastatic disease may resume sunitinib malate within 8 weeks after surgery
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 31 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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-17806 | OTHER | None | None |
| CASE-17806-CC209 | OTHER | Cancer Center IRB | httpsreporternihgovquickSearchP30CA043703 |