NCT00193258

Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Detailed description

Upon determination of eligibility, patients will be receive: Bevacizumab + Erlotinib + Imatinib A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	10mg/kg IV infusion every 2 weeks
DRUG	Erlotinib	150 mg po daily
DRUG	Imatinib	400-600mg daily

Timeline

• Start date: 2004-06-01
• Primary completion: 2011-01-01
• Completion: 2011-08-01
• First posted: 2005-09-19
• Last updated: 2013-01-31
• Results posted: 2013-01-14