Population-based phase i trial of irinotecan and epirubicin

Derick H Lau, Jewel Johl, Minh Huynh, Angela Davies, Michael Tanaka, Primo N Lara, David R Gandara

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


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. In each cohort, irinotecan and epirubicin were administered beginning at a predetermined dose level. The dose for each subsequent 21-day cycle was escalated or de-escalated within each patient based on the dose-limiting toxicity observed in the previous cycle and according to a predetermined schema of dose levels. An MTD was determined for each patient (iMTD) and the iMTDs were used to determine a pMTD for each cohort of patients. RESULTS:: The most common dose-limiting toxicity included neutropenia (51%), asthenia (10%), diarrhea (8%), and nausea/emesis (4%). The iMTDs ranged from dose level -3 to dose level 6. For previously chemotherapy-treated patients, the pMTD was 100 mg/m of irinotecan and 50 mg/m of epirubicin. For chemonaive patients, the pMTD was 150 mg/m of irinotecan and 50 mg/m of epirubicin. CONCLUSIONS:: We have determined the pMTD of irinotecan and epirubicin administered every 3 weeks using a population-based approach. The pMTD is recommended for conducting phase II trials.

Original languageEnglish (US)
Pages (from-to)226-230
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number3
StatePublished - Jun 2008


  • Epirubicin
  • Irinotecan
  • Population-based phase I trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Medicine(all)


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