Gemcitabine with carboplatin for advanced biliary tract cancers: A phase II single institution study

Kerry J. Williams, Joel Picus, Kim Trinkhaus, Chloe C. Fournier, Rama Suresh, Joan S. James, Benjamin R. Tan

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26 Scopus citations


Background: Only recently has a standard chemotherapy regimen, gemcitabine plus cisplatin, been established for advanced biliary tract cancers (BTCs) based on a phase III randomized study. The aim of this phase II single-institution trial was to assess the efficacy and safety of gemcitabine combined with carboplatin in the first-line treatment of patients with advanced BTCs. Methods: Patients with histologically proven BTCs, including cholangiocarcinoma or gallbladder and ampullary carcinomas, were treated with a maximum of nine cycles of intravenous (i.v.) gemcitabine at 1000 mg/m2 over 30 min on days 1 and 8 with i.v. carboplatin dosed at an area-under-the-curve (AUC) of 5 over 60 min on day 1 of a 21-day cycle. Results: A total of 48 patients with advanced BTCs (35 cholangiocarcinoma, 12 gallbladder and 1 ampullary cancer) were enrolled. A median of four cycles were administered (range: 1-9). The overall response rate for evaluable patients was 31.1%. Median progression-free survival, overall survival and 6-month survival rates are 7.8 months, 10.6 months and 85.4%, respectively. The most common grade 3-4 toxicities include neutropenia and thrombocytopenia. Grade 3 or 4 non-haematological toxicities were rare. Conclusions: Gemcitabine combined with carboplatin has activity against advanced BTCs. Our results are comparable to other gemcitabine-platinum or gemcitabine-fluoropyrimidine combinations in advanced BTCs.

Original languageEnglish
Pages (from-to)418-426
Number of pages9
Issue number6
StatePublished - Aug 2010


  • Biliary
  • Chemotherapy < cholangiocarcinoma
  • Chemotherapy < gallbladder
  • Sholangiocarcinoma < liver gallbladder


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