A phase I trial of a bi-weekly combination of capecitabine/irinotecan (XELIRI) then capecitabine/irinotecan/oxaliplatin (XELIRINOX) in solid tumors

e15075 Background: Oral fluoropyrimidines, notably capecitabine, are increasingly replacing IV 5-FU/LV as the backbone of therapy for metastatic colorectal cancer. The bi-weekly combination of capecitabine/irinotecan warrants further examination. Methods: We conducted a phase I trial, in metastatic cancer patients treated for solid tumors, to determine the recommended dose of capecitabine administered orally bid from day 1 to 8 in combination with a bi-weekly fixed-dose of IV irinotecan 180 mg/m2 delivered on day 1 and 14 (FIRST STAGE: XELIRI); and + a bi-weekly fixed-dose of IV oxaliplatin (L-OHP) 85 mg/m2 delivered on day 1 and 14 (Second STAGE: XELIRINOX). Five increasing dose levels (DL1–5) of capecitabine were planned: 1000, 1250, 1500, 1750, and 2000 mg/m2 bid. A pharmacokinetic study of this association was performed. Results: In the first stage, a total of 17 patients were enrolled, with a median age of 60 (range 52–73) years. All patients had an ECOG PS of either 0 (59%), 1 (35%), or 2 (6%). Four...