Carlos R. Becerra, MD

The combination of irinotecan (Camptosar), epirubicin, andcapecitabine (Xeloda) has shown an acceptable toxicity profile. In thisopen-label phase I study, irinotecan was administered IV at a fixeddose of 250 mg/m2 on day 1 in combination with capecitabine at a fixeddose of 1,500 mg/m2 for days 2 to 7 and epirubicin starting at a dose of40 mg/m2 and escalating by 10 mg/m2 in cohorts of three patients forthose with metastatic adenocarcinomas. With the addition of granulocytecolony-stimulating factor (G-CSF [Neupogen]) to the regimen,patients received epirubicin at clinically relevant doses after dose-escalation.Results of the topoisomerase activity will be reported with thefinal results of this phase I study. The dose-limiting toxicity has not yetbeen reached. This combination regimen in patients with upper gastrointestinalmalignancies and breast cancer will be investigated as partof phase II studies, once the dose-limiting toxicity is determined. Theappropriate sequencing of the regimen to maximize clinical efficacywill also be determined.