A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients
|ClinicalTrials.gov Identifier: NCT00421512|
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : November 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma Kidney Cancer||Drug: Bevacizumab and Sunitinib||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
- Drug: Bevacizumab and Sunitinib
On Cycle 1, Day 0, patients will begin treatment with bevacizumab. Sunitinib will begin on Day 1. The starting dose for sunitinib will be 25mg orally daily. sunitinib will be given in a four weeks on-two weeks off schedule. Bevacizumab will begin on Day 0 and will be administered every two weeks at 10mg/kg. A cycle of therapy is 6 weeks. The sunitinib dose escalation portion of the trial will be performed to determine the MTD of sunitinib given in combination with bevacizumab. Once the MTD has been determined, 10 additional patients will be treated at the MTD of sunitinib in combination with bevacizumab.
- 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. [ Time Frame: DLT determination will be based on toxicities observed in Cycles 1 ]
- To assess antitumor activity of the combination of sunitinib and bevacizumab. [ Time Frame: 28 days +/- 3 ]
- To evaluate serum levels of vascular endothelial growth factor (VEGF) [ Time Frame: every 28 days of a cycle +/- 3 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421512
|United States, New York|
|Memorial Sloan-Kettering Cancer Center 1275 York Avenue|
|New York, New York, United States, 10021|
|Principal Investigator:||Robert Motzer, MD||Memorial Sloan Kettering Cancer Center|