Clinical Trial: Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma
Brief 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 Summary:
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.
Sponsor: SCRI Development Innovations, LLC
Current Primary Outcome:
- Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]
- Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 24 months ]
Original Primary Outcome: Objective response rate.
Current Secondary Outcome:
Original Secondary Outcome:
- Progression-free survival
- Overall survival.
Information By: SCRI Development Innovations, LLC
Dates:
Date Received: September 12, 2005
Date Started: June 2004
Date Completion:
Last Updated: January 24, 2013
Last Verified: January 2013