A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma

Cathy Eng, Ramesh K. Ramathan, Michael K. Wong, Scot C. Remick, Lanting Dai, Kurombi T. Wade-Oliver, Sridhar Mani, Hedy L. Kindler

Research output: Contribution to journalArticlepeer-review

38 Scopus citations


Gemcitabine is a commonly used chemotherapy for biliary tree carcinomas, achieving response rates of 10% to 60%. Preclinical studies indicate that fixed dose rate infusion optimizes accumulation of gemcitabine triphosphate and may enhance the clinical activity of gemcitabine. We conducted a phase II study of fixed dose rate gemcitabine in 15 chemotherapy-naive patients with advanced cholangiocarcinoma and gallbladder carcinoma. Gemcitabine was administered at a dose of 1500 mg/m2 over 150 minutes weekly for 3 weeks every 28 days. Fourteen patients were evaluable for response. No complete or partial responses were observed. Two patients (13%) had stable disease lasting a median of 9 weeks. The median time to progression was 9 weeks; median survival was 20 weeks. There was considerable grade 3/4 hematologic toxicity, including neutropenia in 49% of patients, leukopenia in 40%, anemia in 27%, and thrombocytopenia in 27%. Grade 3/4 nonhematologic toxicities were minimal. We conclude that fixed dose rate gemcitabine results in significant myelosuppression and has minimal activity in patients with biliary tree carcinoma.

Original languageEnglish (US)
Pages (from-to)565-569
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number6
StatePublished - Dec 1 2004
Externally publishedYes


  • Biliary carcinoma
  • Cholangiocarcinoma
  • Fixed rate infusion
  • Gallbladder carcinoma
  • Gemcitabine
  • Phase II trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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