Clinical Trial: Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Biliary Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase III Study of Gemcitabine Plus Capecitabine (GEMCAP) Versus Gemcitabine Alone in Advanced Biliary Cancer

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether gemcitabine is more effective when given together with or without capecitabine in treating patients with biliary cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with capecitabine to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced, unresectable, or metastatic biliary cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • To compare overall survival (OS) rates in patients with locally advanced, unresectable or metastatic biliary tree cancer treated with combined gemcitabine hydrochloride and capecitabine vs. gemcitabine hydrochloride alone.

Secondary

  • To compare progression-free survival (PFS) in this patient group.
  • To compare response rates (complete response [CR] and partial response [PR]) in this patient group.
  • To compare stable disease (SD) rates in this patient group.
  • To compare rate of disease control (CR, PR and SD) in this patient group.
  • To estimate and compare response duration in this patient group.
  • To compare the effects of these treatments on measures of quality of life in this patient group using the EORTC QLQ-C30.
  • To compare the nature, severity and frequency of toxicities between the two arms.

OUTLINE: This is a multicenter study. Patients are stratified according to tumour type (cholangiocarcinoma vs. gallbladder or biliary unknown), ECOG performance status (0-1 vs. 2), extent of disease (locally advanced vs. metastatic), and treatment center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (Gemcitabine hydrochloride and capecitabine): Patients receive gemcitabine hydrochloride IV on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absenc
    Sponsor: NCIC Clinical Trials Group

    Current Primary Outcome: Overall survival

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Progression-free survival
    • Response rates (complete response [CR] and partial response [PR])
    • Rate of stable disease (SD)
    • Rate of disease control (CR, PR, and SD)
    • Response duration
    • Quality of Life
    • Toxicity


    Original Secondary Outcome: Same as current

    Information By: Canadian Cancer Trials Group

    Dates:
    Date Received: April 12, 2008
    Date Started: March 2008
    Date Completion:
    Last Updated: December 17, 2012
    Last Verified: December 2012