Bevacizumab And Erlotinib In The Treatment Of Patients With Metastatic Renal Carcinoma (Rcc): Update Of A Phase Ii Multicenter Trial.

4540 Background: Several new drugs which target signaling pathways downstream from the VHL gene product defects characteristic of clear cell RCC have shown antitumor activity in advanced RCC. We previously reported promising results with a combination of bevacizumab and erlotinib in patients (pts) with metastatic RCC. These drugs target 2 pathways critical to the growth and dissemination of clear cell RCC. We now present updated efficacy data after a median follow-up of 16 months. Methods: Eligibility criteria included: metastatic clear cell RCC, 0 or 1 previous systemic regimens, previous nephrectomy, ECOG PS 0 or 1, adequate organ function, no active CNS metastases, no bleeding abnormalities, informed consent. All pts received bevacizumab 10mg/kg IV q 2 weeks, and erlotinib 150mg po daily. Pts were evaluated for response (RECIST criteria) after 8 weeks; treatment continued until tumor progression. Results: Between 2/03 and 1/04, 63 pts were treated: median age 61 years; male/female, 50/13; ECOG 0/1, 36/...