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

Emilio Bajetta, Maria Di Bartolomeo, Roberto Buzzoni, Erminia Ferrario, Katia F. Dotti, Luigi Mariani, Roberto Bajetta, Arpine Gevorgyan, Paola Venturino, Margherita Galassi

Research output: Contribution to journalArticle

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/m2, day 1, q21), capecitabine (1,500-2,000 mg/m2 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/m2 and capecitabine 1,500 mg/m2 per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.

Original languageEnglish
Pages (from-to)67-72
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Volume64
Issue number1
DOIs
Publication statusPublished - Jun 2009

Fingerprint

irinotecan
Toxicity
Colorectal Neoplasms
Fever
Mucositis
Maximum Tolerated Dose
Exanthema
Diarrhea
Safety
Capecitabine
Erlotinib Hydrochloride

Keywords

  • Capecitabine
  • Colorectal cancer
  • Erlotinib
  • Irinotecan

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

Cite this

Dose finding study of erlotinib combined to capecitabine and irinotecan in pretreated advanced colorectal cancer patients. / Bajetta, Emilio; Di Bartolomeo, Maria; Buzzoni, Roberto; Ferrario, Erminia; Dotti, Katia F.; Mariani, Luigi; Bajetta, Roberto; Gevorgyan, Arpine; Venturino, Paola; Galassi, Margherita.

In: Cancer Chemotherapy and Pharmacology, Vol. 64, No. 1, 06.2009, p. 67-72.

Research output: Contribution to journalArticle

Bajetta, Emilio ; Di Bartolomeo, Maria ; Buzzoni, Roberto ; Ferrario, Erminia ; Dotti, Katia F. ; Mariani, Luigi ; Bajetta, Roberto ; Gevorgyan, Arpine ; Venturino, Paola ; Galassi, Margherita. / Dose finding study of erlotinib combined to capecitabine and irinotecan in pretreated advanced colorectal cancer patients. In: Cancer Chemotherapy and Pharmacology. 2009 ; Vol. 64, No. 1. pp. 67-72.
@article{d725a3bbb3eb45a9aceaec3c635f5e1c,
title = "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/m2, day 1, q21), capecitabine (1,500-2,000 mg/m2 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/m2 and capecitabine 1,500 mg/m2 per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.",
keywords = "Capecitabine, Colorectal cancer, Erlotinib, Irinotecan",
author = "Emilio Bajetta and {Di Bartolomeo}, Maria and Roberto Buzzoni and Erminia Ferrario and Dotti, {Katia F.} and Luigi Mariani and Roberto Bajetta and Arpine Gevorgyan and Paola Venturino and Margherita Galassi",
year = "2009",
month = "6",
doi = "10.1007/s00280-008-0852-1",
language = "English",
volume = "64",
pages = "67--72",
journal = "Cancer Chemotherapy and Pharmacology",
issn = "0344-5704",
publisher = "Springer Verlag",
number = "1",

}

TY - JOUR

T1 - Dose finding study of erlotinib combined to capecitabine and irinotecan in pretreated advanced colorectal cancer patients

AU - Bajetta, Emilio

AU - Di Bartolomeo, Maria

AU - Buzzoni, Roberto

AU - Ferrario, Erminia

AU - Dotti, Katia F.

AU - Mariani, Luigi

AU - Bajetta, Roberto

AU - Gevorgyan, Arpine

AU - Venturino, Paola

AU - Galassi, Margherita

PY - 2009/6

Y1 - 2009/6

N2 - 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/m2, day 1, q21), capecitabine (1,500-2,000 mg/m2 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/m2 and capecitabine 1,500 mg/m2 per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.

AB - 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/m2, day 1, q21), capecitabine (1,500-2,000 mg/m2 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/m2 and capecitabine 1,500 mg/m2 per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.

KW - Capecitabine

KW - Colorectal cancer

KW - Erlotinib

KW - Irinotecan

UR - http://www.scopus.com/inward/record.url?scp=67349096951&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67349096951&partnerID=8YFLogxK

U2 - 10.1007/s00280-008-0852-1

DO - 10.1007/s00280-008-0852-1

M3 - Article

C2 - 18936940

AN - SCOPUS:67349096951

VL - 64

SP - 67

EP - 72

JO - Cancer Chemotherapy and Pharmacology

JF - Cancer Chemotherapy and Pharmacology

SN - 0344-5704

IS - 1

ER -