Phase I dose escalation study of MK-0457, a novel Aurora kinase inhibitor, in adult patients with advanced solid tumors.

Purpose: To assess the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), safety, and tolerability of the 24-h continuous intravenous (CIV) infusion of MK-0457, a novel pan-Aurora kinase inhibitor, in patients with advanced solid tumors and to determine the bioavailability of an oral dose of 100 mg MK-0457.

Study Design: MK-0457 was administered as a 24-h CIV infusion every 21 days. Dose escalation proceeded per toxicity criteria.

A phase 1 study of fixed dose rate gemcitabine and irinotecan in patients with advanced pancreatic and biliary cancer.

Background: The combination of a fixed dose rate (FDR) infusion of gemcitabine and irinotecan may have a synergistic effect in the treatment of patients with advanced and metastatic pancreatic and biliary cancer. The current study was conducted to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of the combination.

Methods: There were 32 patients with metastatic pancreatic and advanced unresectable/metastatic biliary adenocarcinoma who were entered into this open-label, phase 1 dose escalation trial.

Oxaliplatin-associated hypersensitivity reactions: clinical presentation and management.

Hypersensitivity reactions to cisplatin and carboplatin have been reported in the literature to occur at a rate of 10%-27%. Initial reports of hypersensitivity reactions to oxaliplatin were low; however, more recently, it appears as if the incidence of hypersensitivity reactions to oxaliplatin is similar to that of the earlier generation platinum agents. The degree of the reaction varies from mild flushing to life-threatening anaphylactic responses.