Dose finding study of erlotinib combined to capecitabine and irinotecan in pretreated advanced colorectal cancer patients.

Abstract:

PURPOSE:This study evaluated the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of erlotinib when combined to irinotecan and capecitabine in pre-treated metastatic colorectal cancer patients. METHODS:Five dose level combinations with irinotecan (from 180 to 240 mg/m(2), day 1, q21), capecitabine (1,500-2,000 mg/m(2) per day, days 2-15, q21) and erlotinib (50-150 mg per day, continuously) were planned. Patients were enrolled in cohorts of three, and evaluated for first cycle acute toxicity. RESULTS:Twenty-one patients were treated. In the first cohort, no DLT was reported, in the second: one DLT (G4 neutropenic fever associated with G3 cutaneous rash and mucositis); in the third dose level: two DLT (G3 diarrhea and G4 neutropenic fever). To confirm these results, other six patients were additionally included and no DLT was observed. CONCLUSIONS:The results documented that erlotinib at the dose of 100 mg per day, irinotecan 180 mg/m(2) and capecitabine 1,500 mg/m(2) per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.

authors

Bajetta E,Di Bartolomeo M,Buzzoni R,Ferrario E,Dotti KF,Mariani L,Bajetta R,Gevorgyan A,Venturino P,Galassi M

doi

10.1007/s00280-008-0852-1

subject

Has Abstract

pub_date

2009-06-01 00:00:00

pages

67-72

issue

1

eissn

0344-5704

issn

1432-0843

journal_volume

64

pub_type

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