Investigational New Drugs

, 25:385

A randomised phase II study of OSI-7904L versus 5-fluorouracil (FU)/leucovorin (LV) as first-line treatment in patients with advanced biliary cancers

  • T. Ciuleanu
  • M. Diculescu
  • N. M. Hoepffner
  • J. Trojan
  • V. Sailer
  • M. Zalupski
  • T. Herrmann
  • A. Roth
  • J. Chick
  • K. Brock
  • D. Albert
  • P. A. Philip
PHASE II STUDIES

DOI: 10.1007/s10637-007-9040-0

Cite this article as:
Ciuleanu, T., Diculescu, M., Hoepffner, N.M. et al. Invest New Drugs (2007) 25: 385. doi:10.1007/s10637-007-9040-0

Summary

The prognosis of advanced biliary tract carcinoma is poor with chemotherapy limited to a palliative role. This randomised study was designed to evaluate the effectiveness of a new liposomal thymidylate synthase inhibitor (TSI), OSI-7904L, in parallel with a modified de Gramont regimen of 5-FU/LV in patients with advanced biliary cancer. Patients with previously untreated advanced or metastatic carcinoma of the biliary tract were randomised to receive either OSI-7904L 12 mg/m2 intravenously every 21 days or a modified de Gramont schedule of 5-FU/LV (intravenous l-LV 200 mg/m2, bolus 5-FU 400 mg/m2 and a 46-h infusion of 5-FU 2,400 mg/m2) every 14 days. Twenty-two patients were randomised, 11 to each group. No patients responded in the OSI-7904L arm, while one patient achieved a partial response in the 5-FU/LV arm. The rates of disease stabilisation were 4/11 (OSI-7904L) and 10/11 (5-FU/LV). Both treatment arms were generally well tolerated. These results show that the activity of OSI-7904L is below a level of clinical relevance in advanced biliary tract cancer, providing only a small degree of disease stabilisation. A simplified de Gramont schedule appears to have marginally more activity. Both treatments were well tolerated.

Keywords

Advanced biliary tract carcinoma Chemotherapy OSI-7904L 5-fluorouracil Leucovorin 

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • T. Ciuleanu
    • 1
  • M. Diculescu
    • 2
  • N. M. Hoepffner
    • 3
  • J. Trojan
    • 3
  • V. Sailer
    • 4
  • M. Zalupski
    • 5
  • T. Herrmann
    • 6
  • A. Roth
    • 7
  • J. Chick
    • 8
  • K. Brock
    • 8
  • D. Albert
    • 9
  • P. A. Philip
    • 10
  1. 1.Oncology Institute “Ion Chiricuta”Cluj-NapocaRomania
  2. 2.Institutul Clinic FundeniCentrul de Gastroenterologie si HepatologieBucurestiRomania
  3. 3.Klinikum der J.W. Groethe-UniversitätFrankfurtGermany
  4. 4.Universitätsklinik Essen, TumorforschungEssenGermany
  5. 5.University of MichiganAnn ArborUSA
  6. 6.Innere Medizin IVUniversitätsklinikum HeidelbergHeidelbergGermany
  7. 7.Oncosurger, HUGGeneva 14Switzerland
  8. 8.OSI PharmaceuticalsOxfordUK
  9. 9.OSI PharmaceuticalsBoulderUSA
  10. 10.Karmanos Cancer InstituteWayne State UniversityDetroitUSA

Personalised recommendations