Phase I study of sunitinib in combination with gemcitabine/capecitabine for the first-line treatment of metastatic or unresectable renal cell carcinoma.

• DOI: 10.1200/jco.2011.29.15_suppl.e15095
• Publication Date: 2017-02-23T18:58:03Z
• Authors: C. Suarez; E. Gallardo; J. Rodon Ahnert; M. Guix; T. Bonfill; F. Pons; M. Beltran; I. Moya; S. Galtes; J. Albanell; J. Carles; J. Bellmunt
• Keywords: Mucositis

e15095 Background: Gemcitabine (G) plus Capecitabine (C) have demonstrated a modest activity in metastatic renal cell cancer (mRCC) patients (pts). The combination of Sunitinib (S) and C resulted an acceptable safety profile pts with advanced solid tumors. We hypothesized that the addition S to G+C advanced/mRCC would be synergistic could increase therapeutic efficacy. Methods: This is open-label, phase I, dose-escalation study assess maximum-tolerated dose (MTD), antitumor (in terms response rate) G naive mRCC. Advanced RCC adequate organ function, performance status (ECOG 0-1), age >18 years, were eligible. Treatment consisted on iv day 1 8, oral bid days 1–14, continuous daily dosing (CDD) schedule, for six cycles (21 per cycle), followed by sunitinib monotherapy, at investigator’s discretion if clinical benefit was maintained. Dose level 1000 850 37.5; 0 650 37.5 (dose -1 500 37.5). Results: 16 enrolled study, median age: 67 yrs, histology: 9 clear cell, 4 papillar sarcomatoid been treated first two levels. In DL1, out had DLT, consisting G3 diarrhea mucositis, G4 thrombocytopenia. Decision made reduce down 0; only 1/12 experienced DLT this DL (mucositis thrombocytopenia G3). Other non-DLTs adverse events asthenia, hand-foot syndrome, diarrhea, infection, neutropenia, epistaxis, low gastrointestinal tract bleeding hypertension. reductions frequent (58% pts) 7 able receive 3 drugs > cycles. One death reported as possibly related drugs. A partial achieved pts, stable disease 6 patients. Conclusions: Although rate observed 0, does not seem manageable most trial there are no signs therapy G/C naïve