A population-based clinical trial of irinotecan and Carboplatin.

Purpose. Phase I trials of anticancer drugs are commonly conducted using the method of modified Fibonacci. We have developed a population-based design for phase I trials of combining anticancer drugs such as irinotecan and carboplatin.

Population-based phase I trial of irinotecan and epirubicin.

Objectives: Preclinical studies have demonstrated anticancer synergism with the combination of inhibitors of topoisomerases I and II. A population-based phase I trial was conducted to determine a population-based maximum tolerated dose (pMTD) for combining 2 topoisomerase inhibitors, irinotecan and epirubicin.

Methods: Two cohorts of patients with advanced solid tumors were enrolled: 27 patients had and 22 patients had not received prior chemotherapy.