Digestive Diseases and Sciences

, Volume 50, Issue 12, pp 2218–2223 | Cite as

A Phase II Trial of Irinotecan in Patients with Previously Untreated Advanced Esophageal and Gastric Adenocarcinoma

  • Peter C. Enzinger
  • Matthew H. Kulke
  • Jeffrey W. Clark
  • David P. Ryan
  • Haesook Kim
  • Craig C. Earle
  • Michele M. Vincitore
  • Ann L. Michelini
  • Robert J. Mayer
  • Charles S. Fuchs
Article
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Accepted:

Abstract

Chemotherapy options for esophagogastric adenocarcinoma remain limited. Irinotecan has demonstrated broad activity in a variety of epithelial malignancies. Forty-six patients with previously untreated, measurable, unresectable, or metastatic esophagogastric adenocarcinoma were enrolled. Patients received irinotecan (125 mg/m2intravenously over 90 min weekly) for 4 consecutive weeks followed by a 2-week rest. Forty-three patients received at least one treatment and were evaluable for response and toxicity. One complete and five partial responses were observed, for an overall response rate of 14% (95% CI, 4–24%). Median survival for all 43 patients was 6.4 months (95% CI, 4.6–8.2 months). Grade 3 to 4 toxicity included 10 patients (23%) with neutropenia, 13 patients (30%) with late diarrhea, 6 patients (14%) with vomiting, and 6 patients (14%) with fatigue. We conclude that although single-agent irinotecan is an active agent for esophagogastric adenocarcinoma, the schedule utilized in this trial is associated with moderate toxicity. When used as a single-agent, a triweekly schedule may be preferable for this patient population.

KeyWords

esophageal adenocarcinoma gastric adenocarcinoma irinotecan chemotherapy phase II trial 
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Copyright information

© Springer Science + Business Media, Inc. 2005

Authors and Affiliations

  • Peter C. Enzinger
    • 1
    • 5
  • Matthew H. Kulke
    • 1
  • Jeffrey W. Clark
    • 3
  • David P. Ryan
    • 3
  • Haesook Kim
    • 2
  • Craig C. Earle
    • 1
  • Michele M. Vincitore
    • 1
  • Ann L. Michelini
    • 1
  • Robert J. Mayer
    • 1
  • Charles S. Fuchs
    • 1
    • 4
  1. 1.Department of Medical OncologyDana-Farber Cancer InstituteBostonUSA
  2. 2.Department of BiostatisticsDana-Farber Cancer InstituteBostonUSA
  3. 3.Division of Hematology/OncologyMassachusetts General HospitalBostonUSA
  4. 4.Department of Channing LaboratoryBrigham and Women's HospitalBostonUSA
  5. 5.Dana-Farber Cancer InstituteBostonUSA

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