Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324870
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2006-05-10
Brief Title:
Vorinostat and Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Suberoylanilide Hydroxamic Acid SAHA in Combination With the VEGF Inhibitor Bevacizumab in Patients With Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This phase III trial is studying the side effects and best dose of vorinostat when given together with bevacizumab and to see how well they work in treating patients with unresectable or metastatic kidney cancer Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor Giving vorinostat together with bevacizumab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of vorinostat SAHA in combination with bevacizumab in patients with unresectable or metastatic renal cell carcinoma Phase I II Determine the recommended dosing in patients treated with this regimen Phase I III Determine the proportion of patients who are progression-free at 6 months after receiving this regimen Phase II IV Determine the clinical response rate in patients treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients Phase II II Determine time to progression and duration of progression-free and overall survival in patients treated with this regimen Phase II III Determine the pharmacodynamic effects in peripheral blood mononuclear cells and tumors before and after treatment with this regimen in these patients Phase II IV Determine the antiproliferative and apoptotic effects of this regimen in these patients Phase II V Determine the antiangiogenic effects of this regimen in these patients Phase II VI Determine the modulation of tumor metabolism and tumor blood flow in patients treated with this regimen Phase II
OUTLINE This is a phase I dose-escalation study of vorinostat SAHA followed by a phase II study
PHASE I Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity An additional 6 patients are treated at the MTD
PHASE II Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
I Determine the safety and tolerability of vorinostat SAHA in combination with bevacizumab in patients with unresectable or metastatic renal cell carcinoma Phase I II Determine the recommended dosing in patients treated with this regimen Phase I III Determine the proportion of patients who are progression-free at 6 months after receiving this regimen Phase II IV Determine the clinical response rate in patients treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients Phase II II Determine time to progression and duration of progression-free and overall survival in patients treated with this regimen Phase II III Determine the pharmacodynamic effects in peripheral blood mononuclear cells and tumors before and after treatment with this regimen in these patients Phase II IV Determine the antiproliferative and apoptotic effects of this regimen in these patients Phase II V Determine the antiangiogenic effects of this regimen in these patients Phase II VI Determine the modulation of tumor metabolism and tumor blood flow in patients treated with this regimen Phase II
OUTLINE This is a phase I dose-escalation study of vorinostat SAHA followed by a phase II study
PHASE I Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity An additional 6 patients are treated at the MTD
PHASE II Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| U01CA070095 | NIH | CTEP | httpsreporternihgovquickSearchU01CA070095 |
| NCI-2009-00093 | REGISTRY | None | None |
| NA 00001107 | None | None | None |
| NCI-6884 | None | None | None |
| JHOC-J0570 | None | None | None |
| CDR0000467800 | None | None | None |
| 6884 | None | None | None |
| JHOC-00001107 | None | None | None |
| J0570 | None | None | None |
| IRB NA 00001107 SKCCC J0570 | OTHER | None | None |
| 6884 | OTHER | None | None |
| P30CA006973 | NIH | None | None |
| U01CA062491 | NIH | None | None |