Multicenter phase II study of oral capecitabine plus irinotecan as first-line chemotherapy in advanced colorectal cancer: a Korean Cancer Study Group trial

Acta Oncol. 2005;44(3):230-5. doi: 10.1080/02841860510029590.

Abstract

A phase II study was conducted to assess the efficacy and tolerability of capecitabine in combination with irinotecan (CAPIRI) in advanced colorectal cancer. Forty-seven patients with previously untreated metastatic or unresectable colorectal adenocarcinoma received capecitabine 1000 mg/m2 twice daily on days 2-15 and intravenous irinotecan 100 mg/m2 on days 1 and 8, every 21 days. A total of 268 cycles of chemotherapy (median 6: range 1-11) were administered. According to an intent-to-treat analysis, the overall response rate was 49% (95% CI, 35-63%). Median time to progression and overall survival were 7.5 months (95% CI, 4.8-10.2) and 19.5 months (95% CI, 15.7-23.8), respectively. The most common grade 3/4 adverse events were diarrhea (24%) and neutropenia (11%). There were no treatment-related deaths. These results indicate that CAPIRI has comparable activity and tolerability to FOLFIRI as first-line treatment for advanced colorectal cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / secondary
  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antineoplastic Agents, Phytogenic / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / analogs & derivatives*
  • Capecitabine
  • Colonic Neoplasms / drug therapy*
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives*
  • Diarrhea / chemically induced
  • Disease Progression
  • Female
  • Fluorouracil / analogs & derivatives
  • Follow-Up Studies
  • Humans
  • Irinotecan
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Prodrugs / administration & dosage
  • Rectal Neoplasms / drug therapy*
  • Remission Induction
  • Survival Rate
  • Topoisomerase I Inhibitors
  • Treatment Outcome

Substances

  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents, Phytogenic
  • Prodrugs
  • Topoisomerase I Inhibitors
  • Deoxycytidine
  • Capecitabine
  • Irinotecan
  • Fluorouracil
  • Camptothecin