Phase I/II study of twenty-four-hour infusion of irinotecan in combination with oral UFT plus leucovorin for metastatic colorectal cancer.

Abstract:

OBJECTIVE:Irinotecan has, in general, been administered as a 90-min infusion. However, several studies have demonstrated that continuous infusion seems to be a promising method of delivering irinotecan. This phase I/II trial was performed to evaluate the efficacy and safety of continuous infusion of irinotecan combined with UFT plus leucovorin (LV) for metastatic colorectal cancer. METHODS:Escalating doses of irinotecan (90-110 mg/m(2)) were administered by 24-hour infusion on day 1. UFT 300 mg/m(2)/day and LV 75 mg/day were administered orally, in 3 divided daily doses, on days 3-7 and 10-14. The treatment cycles were repeated every 2 weeks. RESULTS:In the phase I study, the maximum tolerated dose of irinotecan was 110 mg/m(2) and the recommended dose for the phase II study was determined to be 100 mg/m(2). Thirty-six patients, including 3 patients at the recommended dose in the phase I study, were evaluated in the phase II study. The common grade 3/4 toxicities were leucopenia, neutropenia, diarrhea and anorexia. The response rate was 63.9%, and the median progression-free and overall survival times were 8.3 and 24.6 months, respectively. CONCLUSION:A 24-hour infusion of irinotecan combined with UFT/LV is feasible and active for metastatic colorectal cancer.

journal_name

Oncology

journal_title

Oncology

authors

Sadahiro S,Suzuki T,Maeda Y,Tanaka A,Ishikawa K,Makuuchi H,Murayama C

doi

10.1159/000209963

subject

Has Abstract

pub_date

2009-01-01 00:00:00

pages

338-41

issue

5

eissn

0030-2414

issn

1423-0232

pii

000209963

journal_volume

76

pub_type

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