Final phase II results of NCI 6981: A phase I/II study of sorafenib (S) plus gemcitabine (GEM) and capecitabine (CAP) for advanced renal cell carcinoma (RCC).

e15165 Background: The phase I portion defined toxicity and recommended phase II dose (RP2D): S 200 mg BID D1-21, GEM 750 mg/m2 D1 & D8, and CAP 415 mg/m2 BID D1-D14 in 21-day cycles and demonstrated initial signs of efficacy, with RECIST response rate (RR) 29%, median progression free survival (PFS) 7.5 months (mo), and median overall survival (OS) not reached with follow up of 28.8 mo (Tagawa et al, Am J Clin Oncol 2010) Methods: In this NCI-CTEP sponsored study, a Simon 2-stage, single-arm study of patients (pts) with advanced RCC of any histology with measurable disease who received up to 1 prior immunotherapy and up to 2 prior targeted therapies (excluding sorafenib) was performed at the RP2D. The primary endpoint of the study was RR by RECIST 1.0. At least 2 confirmed responses in the 1st 12 pts were necessary to proceed to the 2nd stage of an additional 23 pts. Results: 11 pts (median age 58) were enrolled: 91% ECOG PS 0-1; 3-clear cell, 5-papillary, 1-chromophobe, and 2-unclassified; 27% with sarc...