Application of a continual reassessment method to a phase I clinical trial of capecitabine in combination with cyclophosphamide and epirubicin (CEX) for inoperable or recurrent breast cancer

Abstract

A phase I clinical trial was started in order to determine the recommended doses of capecitabine and epirubicin, when administered in combination with a fixed dose of cyclophosphamide (600 mg/m2 day 1 q3 weeks) in patients with inoperable or recurrent breast cancer. This study consists of five dose levels with combinations of three levels of epirubicin (75, 90 and 100 mg/m2 day 1 q3 weeks) and three levels of capecitabine (1255, 1657 and 1800 mg/m2/day consecutive administration for 2 weeks followed by 1 week of rest). Dose escalation and de-escalation decisions are based on a continual reassessment method (CRM). We conducted a survey of the clinical oncologists participating in this trial to determine the dose escalation/de-escalation rule, including a prior distribution for model parameters used in the CRM. © 2004 Foundation for Promotion of Cancer Research.