NCT00421512

A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Renal Cell Carcinoma
• Kidney Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-01-12
• Last updated: 2008-11-11

Locations

1 site across 1 country: United States