Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098618
Status:
TERMINATED
Last Update Posted:
2013-07-02
First Post:
2004-12-07
Brief Title:
Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer
Status:
TERMINATED
Status Verified Date:
2013-07
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:
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug Giving sorafenib together with interferon alfa may kill more tumor cells This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the feasibility and tolerability of sorafenib and interferon alfa in patients with locally advanced or metastatic renal cell carcinoma
II Determine the response rate complete response and partial response in patients treated with this regimen
SECONDARY OBJECTIVES
I Determine the progression-free survival and response duration of patients treated with this regimen
II Correlate changes in laboratory parameters with response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients with stable or responding disease are followed every 3 months for 2 years every 6 months for 2 years and then annually for 1 year or until disease progression
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 10 months
I Determine the feasibility and tolerability of sorafenib and interferon alfa in patients with locally advanced or metastatic renal cell carcinoma
II Determine the response rate complete response and partial response in patients treated with this regimen
SECONDARY OBJECTIVES
I Determine the progression-free survival and response duration of patients treated with this regimen
II Correlate changes in laboratory parameters with response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients with stable or responding disease are followed every 3 months for 2 years every 6 months for 2 years and then annually for 1 year or until disease progression
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 10 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 |
|---|---|---|---|
| U01CA099118 | NIH | None | httpsreporternihgovquickSearchU01CA099118 |
| 6258-04-9R0 | None | None | None |
| NCI-6553 | None | None | None |
| CDR0000398171 | None | None | None |