CPT-11 for bile-duct and gallbladder carcinoma: A phase II North Central Cancer Treatment Group (NCCTG) study

Steven R. Alberts, Paul A. Fishkin, Lawrence J. Burgart, Peter J. Cera, Michelle R. Mahoney, Roscoe F. Morton, Patricia A. Johnson, Suresh Nair, Richard M. Goldberg

Research output: Contribution to journalArticlepeer-review

30 Scopus citations

Abstract

Background. Bile-duct and gallbladder carcinomas are rare cancers. Once they have spread beyond the point of surgical resectability, no therapies have shown meaningful long-term benefit. These cancers are typically refractory to standard chemotherapy agents. Based on preclinical work showing activity of CPT-11, we performed a phase II trial to assess its activity in patients with bile-duct or gallbladder carcinomas. Methods. Patients with histologic or cytologic evidence of locally advanced or metastatic bile-duct or gallbladder carcinoma were potentially eligible for this study. Patients meeting study eligibility and who signed an informed consent were given CPT-11 125 mg/m2 weekly for 4 wk followed by a 2-wk break from therapy. The starting dose of CPT-11 was later reduced to 100 mg/m2 grade IV toxicity. Patients continued on treatment if they showed evidence of benefit and tolerated therapy. Results. A total of 39 patients were enrolled, and 36 were evaluable. The overall confirmed response rate was 8%. One CR and two PRs were seen. A high frequency of toxicity was seen. However, no unusual or unexpected toxicities occurred. Conclusion. CPT-11 is ineffective therapy for patients with locally advanced or metastatic bile-duct or gallbladder carcinoma.

Original languageEnglish (US)
Pages (from-to)107-114
Number of pages8
JournalInternational Journal of Gastrointestinal Cancer
Volume32
Issue number2-3
DOIs
StatePublished - 2002

Keywords

  • Bile-duct carcinoma
  • CPT-11
  • Cholangiocarcinoma
  • Clinical trial
  • Gallbladder carcinoma
  • Irinotecan
  • Phase II

ASJC Scopus subject areas

  • Oncology
  • Endocrinology
  • Gastroenterology

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