Conditions: Clear Cell Renal Cell Carcinoma
Keywords: Recurrent clear cell renal cell carcinoma Bevacizumab Erlotinib Imatinib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 94
Healthy volunteers: no

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 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.

Arms:
arm 1: In the phase I portion:

Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course

Erlotinib 150 mg orally daily

Imatinib 300 mg orally daily or 400 mg orally daily

In the phase II portion:

Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle

Erlotinib 150 mg orally daily

Imatinib 400 mg orally daily

Interventions: intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Imatinib
Intervention descriptions: intervention 1: 10mg/kg IV infusion every 2 weeks intervention 2: 150 mg po daily intervention 3: 400-600mg daily

Protocol document: