Oxaliplatin as first-line treatment in inoperable biliary tract carcinoma: a multicenter phase II study

Oncology. 2006;70(4):280-4. doi: 10.1159/000096249. Epub 2006 Oct 12.


Background: A multicenter phase II study was conducted in order to evaluate the efficacy and safety of oxaliplatin as first-line treatment of patients with locally advanced or metastatic carcinoma of the biliary tract.

Patients and methods: Twenty-nine chemo-naïve patients with locally advanced or metastatic biliary tract carcinoma received oxaliplatin 130 mg/m(2) i.v. every 21 days. Patients were treated until tumor progression or unacceptable toxicity.

Results: An objective response (3 complete responses, 3 partial responses) was achieved in 6 patients (20.6%, 95% CI 5.95-35.4). Disease control (complete response, partial response and stable disease) was observed in 14 patients (48.2%). The median time to tumor progression was 3 months (range 0.7-39) and the median overall survival was 7 months (range 1-39). The 1-year survival rate was 32%. Toxicity was mild.

Conclusion: Oxaliplatin is an active agent against biliary tract carcinoma and therefore should be further investigated in combination with other cytotoxic drugs.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / adverse effects*
  • Biliary Tract Neoplasms / drug therapy*
  • Biliary Tract Neoplasms / mortality
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Organoplatinum Compounds / adverse effects*
  • Oxaliplatin
  • Survival Analysis
  • Survival Rate
  • Treatment Outcome


  • Antineoplastic Agents
  • Organoplatinum Compounds
  • Oxaliplatin