ECOG 8802: Phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features

5038 Background: Patients (pts) with RCC containing sarcomatoid features have poor prognoses.Cytokine therapy is ineffective, and experience with mTor inhibitors or multi-targeted tyrosine kinase inhibitors is early. We evaluated Dox/Gem in these pts with locally advanced or metastatic disease to confirm previous activity of this regimen in a single institution trial. Methods: Pts received Dox 50mg/m2 IV push and Gem 1500mg/m2 IV over 30 minutes every 2 weeks (with G-CSF 5 mcg/kg/d days 2 or 3 to 10 or pegfilgrastim 6 mg day 2) until disease progression or unacceptable toxicity. Dose reductions occurred for low granulocytes and or platelets, mucositis, cardiac toxicity, or other grade 3 - 4 toxicities. Dox was discontinued after a cumulative dose of 450 mg/m2 unless pt had normal cardiac function. The study targeted a promising response rate (RR) of 20% vs. 5%, with 90% power and 8% Type I error. A 2-stage design was used; >4 responses were needed for efficacy. Results: From February 2004 to April 2007, 3...