Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421512
Status:
COMPLETED
Last Update Posted:
2008-11-11
First Post:
2007-01-10
Brief Title:
A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients
Status:
COMPLETED
Status Verified Date:
2008-11
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:
The purpose of this study is to test the safety of bevacizumab and sunitinib given in combination for kidney cancer The drugs act to stop blood vessel growth but in different ways They have not been studied together in a previous study We also want to find out what effects good and bad the combination of bevacizumab and sunitinib have on you and your tumor
Detailed Description:
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib administered in combination with bevacizumab for the treatment of patients with metastatic renal cell carcinoma
To assess antitumor activity of the combination of sunitinib and bevacizumab To evaluate serum levels of vascular endothelial growth factor VEGF in patients treated with sunitinib and bevacizumab
Study Design This is a single center open-label Phase 1 study of sunitinib in combination with bevacizumab in patients with advanced metastatic renal cell carcinoma This study is designed to confirm that the two agents can be administered safely in combination Patients will begin treatment with bevacizumab on Day 0 and sunitinib on Day 1 Bevacizumab will be administered intravenously every two weeks Sunitinib will be given orally on a 4 weeks on 2 weeks off schedule DLT determination will be based on toxicities observed in Cycles 1 - a cycle is defined by sunitinib dosing 6 weeks Once the MTD for the combination has been identified 10 additional patients will be enrolled at the MTD to further assess safety and efficacy Patients will be treated with bevacizumab and sunitinib until there is disease progression significant toxicity or withdrawal of patient consent The maximum treatment duration is 24 months
To assess antitumor activity of the combination of sunitinib and bevacizumab To evaluate serum levels of vascular endothelial growth factor VEGF in patients treated with sunitinib and bevacizumab
Study Design This is a single center open-label Phase 1 study of sunitinib in combination with bevacizumab in patients with advanced metastatic renal cell carcinoma This study is designed to confirm that the two agents can be administered safely in combination Patients will begin treatment with bevacizumab on Day 0 and sunitinib on Day 1 Bevacizumab will be administered intravenously every two weeks Sunitinib will be given orally on a 4 weeks on 2 weeks off schedule DLT determination will be based on toxicities observed in Cycles 1 - a cycle is defined by sunitinib dosing 6 weeks Once the MTD for the combination has been identified 10 additional patients will be enrolled at the MTD to further assess safety and efficacy Patients will be treated with bevacizumab and sunitinib until there is disease progression significant toxicity or withdrawal of patient consent The maximum treatment duration is 24 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