Irinotecan hepatic arterial infusion chemotherapy for hepatic metastases from colorectal cancer: results of a phase I clinical study

Tumori. 2001 Nov-Dec;87(6):388-90. doi: 10.1177/030089160108700606.

Abstract

Background: Hepatic arterial infusion chemotherapy is a promising approach in liver metastases from colorectal cancer, but chemical hepatitis, biliary sclerosis, arterial thrombosis and right upper quadrant pain are limiting factors. Irinotecan (CPT-11) is an active drug in colorectal cancer. We planned a short hepatic arterial infusion of CPT-11 to describe the toxicity, to determine the dose-limiting toxicity, and to define the doses of CPT-11 to be recommended for phase II studies.

Patients and methods: Fourteen patients with a median liver substitution of 30% (10-60%) were enrolled. All patients received hepatic arterial infusion chemotherapy with CPT-11 on an outpatient basis every 3 weeks as a short, 30-min infusion.

Results: At 240 mg/m2, 2 of 4 patients experienced grade 4 diarrhea and neutropenia, and 3 of them also reported grade 4 abdominal pain of the right upper quadrant. The maximum tolerated dose was reached at 240 mg/m2. The recommended doses of CPT-11 for phase II studies is 200 mg/m2, given every 3 weeks.

Conclusions: CPT-11 presents a low hepatic toxic profile and could be considered a new active drug, suitable for hepatic arterial infusion in liver metastases from colorectal cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic / administration & dosage*
  • Antineoplastic Agents, Phytogenic / adverse effects*
  • Camptothecin / administration & dosage*
  • Camptothecin / adverse effects*
  • Camptothecin / analogs & derivatives
  • Colorectal Neoplasms / pathology*
  • Enzyme Inhibitors / administration & dosage*
  • Enzyme Inhibitors / adverse effects*
  • Female
  • Hepatic Artery
  • Humans
  • Infusions, Intra-Arterial
  • Irinotecan
  • Liver / drug effects*
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / secondary
  • Male
  • Middle Aged
  • Topoisomerase I Inhibitors
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Phytogenic
  • Enzyme Inhibitors
  • Topoisomerase I Inhibitors
  • Irinotecan
  • Camptothecin