A phase I and pharmacokinetic (PK) study of weekly docetaxel (D), cisplatin (P), and daily capecitabine (C) (DPC) in patients with advanced solid tumors

Abstract

2092 Background: D, P & C are 3 active chemotherapeutic agents with different mechanisms of activity. We investigated a weekly D & P with twice daily C regimen in patients (pts) with advanced solid tumors in a phase I study. Methods: Three pts were treated at each dose level (DL) given no dose-limiting toxicity (DLT) was noted. D & P were each given intravenously over 30 min on D1 & D8, and C was given orally BID on D1-D14; the cycle was repeated every 21 days. DL of D, P & C (mg/m2) were: 1) 20, 20, 600; 2) 20, 20; 825; 3) 27, 20; 825; 4) 27, 27; 825; 5) 36, 27; 825; 6) 36, 36; 825. DLT was defined as any treatment-induced grade (G) 4 neutropenia > 1 week, febrile neutropenia, G4 thrombocytopenia, G3 or higher non-hematologic toxicity (diarrhea must be > 1 day; nausea appropriately medicated), and delay in treatment of ≥ 2 weeks. CT scans were performed every 2 cycles. PK studies of D were performed on D1/cycle 1 with C and on D1/cycle 2 without C. D plasma concentrations were measured by an LC-MS/MS ass...